A Phase 3 interventional study of Atezolizumab and Bevacizumab in Carcinoma, Hepatocellular, sponsored by Hoffmann-La Roche. Completed at 119 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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Among 41 studies testing atezolizumab in Carcinoma, Hepatocellular — 17 open to participants now, 29 under way, 7 of them phase 3. atezolizumab · Carcinoma, Hepatocellular.
Among the 41 studies testing atezolizumab in Carcinoma, Hepatocellular, this one is the 4th largest by enrollment, is one of 2 that started in 2018, is one of 11 in phase 3, and was the 2nd registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →17 of the 41 studies testing atezolizumab in Carcinoma, Hepatocellular are open now, in 11 countries. Recruiting first, the newest first:
Fundacion Clinic per a la Recerca Biomédica · Sites in Spain
Ages 18+
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–90
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–75
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
By country, each count listing its studies:
atezolizumab: first FDA approval 2016 (TECENTRIQ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, atezolizumab is the treatment under test here. Read study by study →
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 21 · Phase 3 12 · Phase 4 2
First in 2017; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 558 is above the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 40 across the 41 interventional studies. Of the 11 that completed or were terminated, 8 (73%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 41 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
21 studies in Carcinoma, Hepatocellular by Hoffmann-La Roche: 1 open now, 6 under way, 3 of them phase 3. Of 15 finished, 6 (40%) have results posted.
Among the 21 studies in Carcinoma, Hepatocellular by Hoffmann-La Roche, this one is the 3rd largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2018, is one of 7 in phase 3, and was the 8th registered.
Hoffmann-La Roche’s Carcinoma, Hepatocellular studies by the year they started, since 2005.
10 of the studies testing atezolizumab in Carcinoma, Hepatocellular that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04803994Phase 3Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestThe ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma | 2027-07 |
| NCT07192185Sun Yat-sen UniversitySystemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab | 2026-12-01 |
| NCT06066138National Cancer Institute (NCI)A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing | 2027-01-31 |
| NCT05377034National Cancer Centre, SingaporeMultinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients | 2027-02-15 |
| NCT05516628National Cancer Centre, SingaporeDeep, Multi-omics Phenotyping to Predict Response, Resistance and Recurrence to Adjuvant Atezolizumab Plus Bevacizumab in Resected Hepatocellular Carcinoma | 2027-03 |
Add all 10 to your calendar (.ics) → With an account.
Among the 41 studies testing atezolizumab in Carcinoma, Hepatocellular, from their registry updates:
Among Hoffmann-La Roche’s 21 in Carcinoma, Hepatocellular:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.
The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator
Drug: Atezolizumab · Drug: Bevacizumab
Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator
Drug: Sorafenib
Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
Overall Survival (OS) in the Global Population
OS was defined as the time from randomization to death from any cause.
Time frame: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Overall Survival (OS) in the China Population
OS was defined as the time from randomization to death from any cause.
Time frame: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
PFS-IRF Per RECIST v1.1 in the China Population
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-IRF Per HCC mRECIST in the Global Population
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
TTP-IRF Per HCC mRECIST in the Global Population
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Overall Survival by Baseline AFP in the Global Population
OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
Time frame: From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Time to Deterioration (TTD) in the Global Population
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Number of Participants With Adverse Events (AEs) in the Global Population
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to end of study (up to approximately 56 months)
Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
Time frame: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
Time frame: Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-IRF Per HCC mRECIST in the China Population
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
TTP-IRF Per HCC mRECIST in the China Population
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Time to Deterioration (TTD) in the China Population
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
Time frame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Number of Participants With Adverse Events (AEs) in the China Population
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to end of study (up to approximately 56 months)
Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
Time frame: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
Time frame: Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)
Participants were enrolled at 117 sites in 17 countries: Australia, Canada, China, Czech Republic, Germany, Spain, France, United Kingdom, Hong Kong, Italy, Japan, Republic of Korea, Poland, Russian Federation, Singapore, Taiwan, United States.
| Milestone | Sorafenib - Global | Atezolizumab + Bevacizumab - Global | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|---|---|
| Started | 165 | 336 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 165 | 336 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 6 | 0 | 0 |
| Withdrew: Death | 115 | 228 | 0 | 0 |
| Withdrew: Withdrawal by subject | 20 | 21 | 0 | 0 |
| Withdrew: Reason unspecified | 0 | 1 | 0 | 0 |
| Withdrew: Study ended by sponsor | 26 | 80 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
| Milestone | Sorafenib - Global | Atezolizumab + Bevacizumab - Global | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|---|---|
| Started | 0 | 0 | 61 | 133 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 61 | 133 |
| Withdrew: Lost to follow-up | 0 | 0 | 2 | 3 |
| Withdrew: Death | 0 | 0 | 46 | 88 |
| Withdrew: Withdrawal by subject | 0 | 0 | 8 | 6 |
| Withdrew: Study ended by sponsor | 0 | 0 | 5 | 36 |
OS was defined as the time from randomization to death from any cause.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| At CCOD 18 months | 13.24 (10.41 to NA) | NA (NA to NA) |
| At CCOD 30 months | 13.40 (11.37 to 16.85) | 19.22 (17.02 to 23.66) |
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population | 4.27 (3.98 to 5.55) | 6.83 (5.75 to 8.28) |
OS was defined as the time from randomization to death from any cause.
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| At CCOD 18 months | 11.37 (6.74 to NA) | NA (13.50 to NA) |
| At CCOD 30 months | 11.37 (6.74 to 16.07) | 24.05 (17.12 to NA) |
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| PFS-IRF Per RECIST v1.1 in the China Population | 3.19 (2.56 to 4.76) | 5.72 (4.17 to 8.28) |
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
| percentage of participants | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population | 11.9 (7.35 to 18.03) | 27.3 (22.54 to 32.48) |
ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
| percentage of participants | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population | 13.3 (8.42 to 19.60) | 33.2 (28.13 to 38.64) |
ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
| percentage of participants | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population | 5.5 (2.54 to 10.16) | 25.6 (21.01 to 30.61) |
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population | 6.28 (4.67 to NA) | NA (NA to NA) |
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population | 6.28 (4.86 to NA) | NA (NA to NA) |
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population | NA (5.39 to NA) | 13.08 (13.08 to NA) |
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| PFS-IRF Per HCC mRECIST in the Global Population | 4.24 (3.98 to 5.45) | 6.83 (5.72 to 7.69) |
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population | 2.89 (2.76 to 4.17) | 7.06 (5.68 to 8.44) |
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population | 5.59 (4.21 to 7.72) | 8.57 (6.83 to 9.86) |
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| TTP-IRF Per HCC mRECIST in the Global Population | 5.55 (4.21 to 7.69) | 8.28 (6.80 to 9.86) |
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population | 3.98 (2.83 to 4.30) | 8.54 (6.93 to 9.92) |
OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| AFP <400 ng/mL | 13.93 (11.73 to NA) | NA (NA to NA) |
| AFP >/=400 ng/mL | 9.10 (5.75 to NA) | 12.78 (10.15 to NA) |
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| AFP <400 ng/mL | 4.40 (4.01 to 6.21) | 8.28 (6.83 to 11.04) |
| AFP >/=400 ng/mL | 4.14 (2.76 to 5.26) | 5.19 (3.94 to 6.77) |
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| AFP <400 ng/mL | 3.98 (2.79 to 5.62) | 8.41 (7.06 to 9.66) |
| AFP >/=400 ng/mL | 2.79 (1.58 to 3.98) | 5.42 (4.17 to 6.90) |
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
| months | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Physical Functioning | 4.86 (3.48 to 6.24) | 13.14 (9.69 to NA) |
| Role Functioning | 3.58 (2.20 to 5.98) | 9.13 (6.51 to NA) |
| GHS/QoL | 3.58 (3.02 to 6.97) | 11.24 (5.98 to NA) |
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Participants | Sorafenib - Global | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Number of Participants With Adverse Events (AEs) in the Global Population | 154 | 322 |
| micrograms/milliliter (mcg/mL) | Atezolizumab + Bevacizumab - Global |
|---|---|
| Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population | 398 ± 132 |
| mcg/mL | Atezolizumab + Bevacizumab - Global |
|---|---|
| Pre-dose Cycle 2, Day 1 | 79.2 ± 50.2 |
| Pre-dose Cycle 3, Day 1 | 101 ± 55.4 |
| Pre-dose Cycle 4, Day 1 | 131 ± 63.7 |
| Pre-dose Cycle 8, Day 1 | 145 ± 61.7 |
| Pre-dose Cycle 12, Day 1 | 168 ± 82.9 |
| Pre-dose Cycle 16, Day 1 | 167 ± 65.0 |
| percentage of participants | Atezolizumab + Bevacizumab - Global |
|---|---|
| Baseline | 2.2 |
| Post-baseline | 29.6 |
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
| percentage of participants | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population | 6.7 (1.85 to 16.20) | 24.6 (17.49 to 32.94) |
ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
| percentage of participants | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population | 8.5 (2.81 to 18.68) | 29.7 (21.94 to 38.40) |
ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
| percentage of participants | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population | 4.9 (1.03 to 13.71) | 21.1 (14.47 to 28.97) |
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population | NA (4.86 to NA) | NA (8.15 to NA) |
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population | 4.86 (4.47 to NA) | NA (8.15 to NA) |
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population | 5.55 (4.17 to NA) | NA (NA to NA) |
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| PFS-IRF Per HCC mRECIST in the China Population | 3.19 (2.56 to 4.76) | 5.72 (4.17 to 8.11) |
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population | 2.83 (2.73 to 3.98) | 5.55 (4.21 to 8.34) |
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population | 4.14 (2.76 to 10.15) | 7.00 (5.45 to 9.49) |
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| TTP-IRF Per HCC mRECIST in the China Population | 4.14 (2.76 to 10.15) | 7.00 (5.45 to 9.49) |
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population | 2.83 (2.79 to 4.17) | 6.83 (5.32 to 9.33) |
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
| months | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|
| Physical Functioning | 5.62 (2.10 to NA) | 13.14 (9.69 to NA) |
| Role Functioning | NA (2.14 to NA) | NA (7.20 to NA) |
| GHS/QoL | 3.58 (1.48 to 9.82) | 9.76 (6.24 to NA) |
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Participants | Sorafenib - China | Atezolizumab + Bevacizumab - Global |
|---|---|---|
| Number of Participants With Adverse Events (AEs) in the China Population | 56 | 131 |
| mcg/mL | Atezolizumab + Bevacizumab - China |
|---|---|
| Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population | 456 ± 153 |
| mcg/mL | Atezolizumab + Bevacizumab - China |
|---|---|
| Pre-dose Cycle 2, Day 1 | 92.6 ± 65.7 |
| Pre-dose Cycle 3, Day 1 | 105 ± 36.8 |
| Pre-dose Cycle 4, Day 1 | 143 ± 61.4 |
| Pre-dose Cycle 8, Day 1 | 177 ± 61.9 |
| Pre-dose Cycle 12, Day 1 | 201 ± 97.6 |
| Pre-dose Cycle 16, Day 1 | 208 ± 79.4 |
| percentage of participants | Atezolizumab + Bevacizumab - China |
|---|---|
| Baseline | 1.1 |
| Post-baseline | 20.2 |
Collected over Up to end of study (up to approximately 56 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sorafenib - Global | 115/165 (69.7%) | 51/156 (32.7%) | 147/156 (94.2%) |
| Atezolizumab + Bevacizumab - Global | 228/336 (67.9%) | 171/329 (52%) | 311/329 (94.5%) |
| Sorafenib - China | 46/61 (75.4%) | 12/58 (20.7%) | 55/58 (94.8%) |
| Atezolizumab + Bevacizumab - China | 88/133 (66.2%) | 54/132 (40.9%) | 129/132 (97.7%) |
| Event | Sorafenib - Global | Atezolizumab + Bevacizumab - Global | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|---|---|
| AscitesGastrointestinal disorders | 1/156 | 13/329 | 0/58 | 6/132 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 2/156 | 5/329 | 1/58 | 5/132 |
| Hepatic function abnormalHepatobiliary disorders | 1/156 | 1/329 | 0/58 | 5/132 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/156 | 2/329 | 2/58 | 1/132 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 3/156 | 11/329 | 0/58 | 3/132 |
| PyrexiaGeneral disorders | 2/156 | 11/329 | 1/58 | 4/132 |
| Oesophageal varices haemorrhageGastrointestinal disorders | 1/156 | 10/329 | 0/58 | 2/132 |
| SepsisInfections and infestations | 0/156 | 8/329 | 0/58 | 1/132 |
| AnaemiaBlood and lymphatic system disorders | 2/156 | 5/329 | 1/58 | 3/132 |
| PneumoniaInfections and infestations | 1/156 | 5/329 | 0/58 | 3/132 |
| Event | Sorafenib - Global | Atezolizumab + Bevacizumab - Global | Sorafenib - China | Atezolizumab + Bevacizumab - China |
|---|---|---|---|---|
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 76/156 | 6/329 | 33/58 | 2/132 |
| ProteinuriaRenal and urinary disorders | 13/156 | 107/329 | 11/58 | 68/132 |
| DiarrhoeaGastrointestinal disorders | 79/156 | 75/329 | 26/58 | 20/132 |
| HypertensionVascular disorders | 38/156 | 118/329 | 12/58 | 54/132 |
| Aspartate aminotransferase increasedInvestigations | 28/156 | 77/329 | 19/58 | 41/132 |
| Blood bilirubin increasedInvestigations | 23/156 | 59/329 | 14/58 | 35/132 |
| Decreased appetiteMetabolism and nutrition disorders | 39/156 | 68/329 | 12/58 | 27/132 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 11/156 | 42/329 | 5/58 | 32/132 |
| FatigueGeneral disorders | 30/156 | 76/329 | 6/58 | 17/132 |
| Alanine aminotransferase increasedInvestigations | 14/156 | 56/329 | 12/58 | 30/132 |
The intent-to-treat (ITT) population included 558 participants (All) with 501 in the Global population. An additional 57 participants enrolled in the China Extension. The China population included 137 Chinese participants from the Global population plus 57 participants from the China Extension. The Global population and China population were analyzed separately.
| Age, Continuous(years) | Sorafenib - All | Atezolizumab + Bevacizumab - All | Total |
|---|---|---|---|
| Global | 64.4 ± 10.9 | 62.9 ± 11.9 | 63.4 ± 11.6 |
| China | 57.5 ± 12.7 | 55.3 ± 12.0 | 56.0 ± 12.3 |
| Sex: Female, Male(Participants) | Sorafenib - All | Atezolizumab + Bevacizumab - All | Total |
|---|---|---|---|
| Global — Female | 28 | 59 | 87 |
| Global — Male | 137 | 277 | 414 |
| China — Female | 12 | 17 | 29 |
| China — Male | 49 | 116 | 165 |
| Ethnicity (NIH/OMB)(Participants) | Sorafenib - All | Atezolizumab + Bevacizumab - All | Total |
|---|---|---|---|
| Global — Hispanic or Latino | 4 | 9 | 13 |
| Global — Not Hispanic or Latino | 149 | 306 | 455 |
| Global — Unknown or Not Reported | 12 | 21 | 33 |
| China — Hispanic or Latino | 0 | 0 | 0 |
| China — Not Hispanic or Latino | 61 | 133 | 194 |
| China — Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sorafenib - All | Atezolizumab + Bevacizumab - All | Total |
|---|---|---|---|
| Global — American Indian or Alaska Native | 1 | 0 | 1 |
| Global — Asian | 96 | 188 | 284 |
| Global — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Global — Black or African American | 4 | 6 | 10 |
| Global — White | 52 | 123 | 175 |
| Global — More than one race | 0 | 0 | 0 |
| Global — Unknown or Not Reported | 12 | 19 | 31 |
| China — American Indian or Alaska Native | 0 | 0 | 0 |
| China — Asian | 61 | 133 | 194 |
| China — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| China — Black or African American | 0 | 0 | 0 |
| China — White | 0 | 0 | 0 |
| China — More than one race | 0 | 0 | 0 |
| China — Unknown or Not Reported | 0 | 0 | 0 |
Showing the first 100 of 119 sites across 17 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Ran from Mar 2018 to primary completion in Aug 2020, 29 months.
Results were first posted in Nov 2021, 1 year 2 months after primary completion.
Of 52 industry-sponsored phase 3 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 63. This study's 29 months is below that.
Counting every sponsor, half of 138 studies reached it within 56 months; a quarter within 43 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Atezolizumab · Bevacizumab