A Phase 3 interventional study of Tislelizumab and Sorafenib in Hepatocellular Carcinoma (HCC), sponsored by BeiGene. Completed at 122 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by BeiGene · Phase 3, Interventional, and Treatment
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Among 43 studies testing tislelizumab in Carcinoma, Hepatocellular — 23 open to participants now, 25 under way, 2 of them phase 3. tislelizumab · Carcinoma, Hepatocellular.
Among the 43 studies testing tislelizumab in Carcinoma, Hepatocellular, this one has the largest enrollment, is the only one that started in 2017, is one of 4 in phase 3, and was the 1st registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →23 of the 43 studies testing tislelizumab in Carcinoma, Hepatocellular are open now, in 2 countries. Recruiting first, the newest first:
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
First Hospital of China Medical University · Sites in China
Ages 18–80
Tongji Hospital · Sites in China
Ages 18+
Haibo Shao · Sites in China
Ages 18–80
Sir Run Run Shaw Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
tislelizumab: first FDA approval 2024 (TEVIMBRA), first EMA approval 2023. 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.
43 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 3 · Phase 2 32 · Phase 3 4 · Phase 4 1
First in 2017; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 684 is above the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 40 across the 43 interventional studies. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 43 have an industry lead sponsor. The 10 most frequent:
This study is registered under BeiGene, one of the names counted as BeOne Medicines. Under that name alone:
BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.
Of its 55 completed or terminated interventional studies of FDA-regulated products, 32 (58%) have results posted.
BeOne Medicines has 9 studies filed under Carcinoma, Hepatocellular — fewer than ten, so there is no comparison to draw.
5 of the studies testing tislelizumab in Carcinoma, Hepatocellular that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04615143Sun Yat-sen UniversityTislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC | 2026-12-01 |
| NCT07413354Tongji HospitalTislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma | 2027-03-31 |
| NCT07483359First Hospital of China Medical UniversityConversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus | 2027-06 |
| NCT05366829Rutgers, The State University of New JerseyTislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma | 2027-06-01 |
| NCT07243691Sir Run Run Shaw HospitalStudy on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma | 2027-11-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 43 studies testing tislelizumab in Carcinoma, Hepatocellular, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.
Safety Run-In Sub-study Eligibility Criteria: The study included adult Japanese participants (≥ 20 years) with confirmed hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) Stage C or B. Eligible participants had either received, were ineligible for, or declined standard treatment. Additional requirements were a A classification within 7 days before enrollment, at least one per (RECIST) version 1.1, and an (ECOG) Performance Status score of ≤ 1.
Main Study Key Inclusion Criteria:
Main Study Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability.
Drug: Tislelizumab
Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy.
Drug: Tislelizumab
Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit.
Drug: Sorafenib
Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W)
Also known as: BGB-A317
Sorafenib 400 mg orally (PO) twice daily (BID)
Also known as: Nexavar, BAY43-9006
Safety Run-in Sub-study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).
Time frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)
Safety Run-in Sub-study: Serum Concentration of Tislelizumab
Serum concentration of tislelizumab was a pre-specified primary endpoint for the sub-study only.
Time frame: Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks).
Main Study: Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. Overall survival was a pre-specified primary endpoint for the main study only.
Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Overall Response Rate (ORR) as Assessed by Blinded Independent Review Committee (BIRC)
Defined as the percentage of participants who had partial response or complete response as determined by Blinded Independent Review Committee (BIRC) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants with measurable disease at baseline. ORR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Overall Response Rate (ORR) as Assessed by the Investigator
Defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized participants with measurable disease at baseline.
Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Progression Free Survival (PFS) as Assessed by BIRC
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the BIRC per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS. PFS was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Progression Free Survival (PFS) Assessed by the Investigator
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS.
Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Duration of Response (DOR) as Assessed by BIRC
Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as determined by the BIRC per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology. DOR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Duration of Response (DOR) Assessed by the Investigator
Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology.
Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Time to Progression (TTP) Assessed by BIRC
Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the BIRC per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Time to Progression (TTP) as Assessed by the Investigator
Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the investigator per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not a pre-specified sub-study endpoint.
Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Safety Run-in Sub-study: Overall Survival
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
Time frame: Up a to 64 months
Disease Control Rate (DCR) as Assessed by BIRC
Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the BIRC per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study.
Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Disease Control Rate (DCR) as Assessed by the Investigator
Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the investigator per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study.
Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Clinical Benefit Rate (CBR) as Assessed by BIRC
Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the BIRC per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study.
Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Clinical Benefit Rate (CBR) as Assessed by the Investigator
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the investigator per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study.
Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 Questions (EORTC QLQ HCC 18) Index Score at Cycle 4
The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The EORTC QLQ-HCC18 was not assessed for participants in the sub-study.
Time frame: Baseline to Cycle 4 (each cycle was 21 days)
Change From Baseline in the European EORTC QLQ HCC 18 Index Score at Cycle 6
The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The HEORTC QLQ-HCC18 was not assessed in participants in the sub-study.
Time frame: Baseline to Cycle 6 (Each cycle was 21 days)
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Score at Cycle 4
The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study.
Time frame: Baseline to Cycle 4 (each cycle was 21 days)
Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Score at Cycle 6
The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study.
Time frame: Baseline to Cycle 6 (each cycle was 21 days)
Change From Baseline in the European Quality of Life 5 Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) at Cycle 4
The EQ-5D-5L comprises a descriptive module and a Visual Analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study.
Time frame: Baseline to Cycle 4 (each cycle was 21 days)
Change From Baseline in the EQ-5D-5L VAS at Cycle 6
The EQ-5D-5L comprises a descriptive module and a visual analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study.
Time frame: Baseline to Cycle 6 (each cycle was 21 days)
Main Study: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).
Time frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the study completion analysis cutoff on December 14th, 2023 (a maximum of 61 months for participants in Arm A and 63 months for participants in Arm B).
Safety Run-in Sub-study: Number of Participants Who Developed Anti-tislelizumab Antibodies
Treatment-emergent anti-drug antibodies (ADA): participants who were ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA: participants who were ADA positive at baseline that was boosted to a 4-fold or higher-level following drug administration. ADA assessments were not performed for participants enrolled in the main study.
Time frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)
The main study enrolled participants across centers in Asia, Europe, and the U.S. The first participant consented on December 18, 2017, and the study concluded on December 14, 2023. In Japan, a safety run-in sub-study was conducted to evaluate tislelizumab's safety and tolerability in Japanese patients with hepatocellular carcinoma (HCC). Sub-study participants were not assessed for the same primary and secondary endpoints specified for the main study.
| Milestone | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|---|
| Started | 10 | 342 | 332 |
| Treated | 10 | 338 | 324 |
| Completed | 0 | 0 | 0 |
| Not completed | 10 | 342 | 332 |
| Withdrew: Lost to follow-up | 0 | 7 | 6 |
| Withdrew: Withdrawal by subject | 0 | 15 | 19 |
| Withdrew: Study closed by sponsor | 3 | 46 | 33 |
| Withdrew: Transfer to long term extension (bgb-a317-290-lte1) or post trial supply (pts) | 0 | 15 | 0 |
| Withdrew: Death | 7 | 259 | 273 |
| Withdrew: Physician decision | 0 | 0 | 1 |
An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).
| Participants | Safety Run-In Sub-study |
|---|---|
| TEAEs | 8 |
| SAEs | 1 |
Serum concentration of tislelizumab was a pre-specified primary endpoint for the sub-study only.
| µg/mL | Safety Run-In Sub-study |
|---|---|
| Cycle 1 End of Infusion | 63.21 ± 22.304 |
| Cycle 1: 24 Hours Post Dose | 53.04 ± 20.901 |
| Cycle 1: 72 Hours Post Dose | 42.06 ± 23.649 |
| Cycle 1: 8 Days Post Dose | 32.61 ± 16.920 |
| Cycle 1: 15 Days Post Dose | 23.74 ± 18.328 |
| Cycle 5 Day 1: Predose | 27.17 ± 34.436 |
| Cycle 5 Day 1: End of Infusion | 87.54 ± 27.508 |
| Cycle 5: 24 Hours Post Dose | 80.54 ± 27.006 |
| Cycle 5: 72 Hours Post Dose | 64.80 ± 23.837 |
| Cycle 5: 8 Days Post Dose | 52.65 ± 26.759 |
| Cycle 5: 15 Days Post Dose | 37.57 ± 24.982 |
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. Overall survival was a pre-specified primary endpoint for the main study only.
| Months | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Main Study: Overall Survival (OS) | 15.9 (13.2 to 19.7) | 14.1 (12.6 to 17.4) |
Defined as the percentage of participants who had partial response or complete response as determined by Blinded Independent Review Committee (BIRC) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants with measurable disease at baseline. ORR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
| percentage of participants | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Overall Response Rate (ORR) as Assessed by Blinded Independent Review Committee (BIRC) | 14.3 (10.8 to 18.5) | 5.4 (3.2 to 8.4) |
Defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized participants with measurable disease at baseline.
| percentage of participants | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|---|
| Overall Response Rate (ORR) as Assessed by the Investigator | 20 (2.5 to 55.6) | 15.5 (11.8 to 19.8) | 5.7 (3.5 to 8.8) |
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the BIRC per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS. PFS was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
| months | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by BIRC | 2.1 (2.1 to 3.5) | 3.4 (2.2 to 4.1) |
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS.
| Months | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|---|
| Progression Free Survival (PFS) Assessed by the Investigator | 2.1 (1.9 to 16.0) | 2.1 (2.1 to 2.3) | 4.0 (2.7 to 4.1) |
Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as determined by the BIRC per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology. DOR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
| months | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Duration of Response (DOR) as Assessed by BIRC | 36.1 (16.8 to NA) | 11.0 (6.2 to 14.7) |
Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology.
| Months | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|---|
| Duration of Response (DOR) Assessed by the Investigator | NA (NA to NA) | 25.2 (18.1 to 46.8) | 13.8 (6.2 to 20.3) |
Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the BIRC per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
| Months | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Time to Progression (TTP) Assessed by BIRC | 2.2 (2.1 to 3.6) | 4.1 (2.2 to 4.1) |
Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the investigator per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not a pre-specified sub-study endpoint.
| months | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Time to Progression (TTP) as Assessed by the Investigator | 2.1 (2.1 to 3.3) | 4.1 (3.4 to 4.2) |
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
| months | Safety Run-In Sub-study |
|---|---|
| Safety Run-in Sub-study: Overall Survival | 29.7 (3.0 to NA) |
Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the BIRC per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study.
| percentage of participants | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Disease Control Rate (DCR) as Assessed by BIRC | 44.2 | 50.3 |
Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the investigator per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study.
| percentage of participants | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Disease Control Rate (DCR) as Assessed by the Investigator | 44.2 | 52.4 |
Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the BIRC per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study.
| percentage of participants | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Clinical Benefit Rate (CBR) as Assessed by BIRC | 25.4 | 24.4 |
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the investigator per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study.
| percentage of participants | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Clinical Benefit Rate (CBR) as Assessed by the Investigator | 25.7 | 28.9 |
The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The EORTC QLQ-HCC18 was not assessed for participants in the sub-study.
| score on a scale | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 Questions (EORTC QLQ HCC 18) Index Score at Cycle 4 | 1.6 (0.4 to 2.9) | 3.9 (2.6 to 5.2) |
The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The HEORTC QLQ-HCC18 was not assessed in participants in the sub-study.
| score on a scale | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Change From Baseline in the European EORTC QLQ HCC 18 Index Score at Cycle 6 | 2.2 (0.6 to 3.7) | 4.9 (3.2 to 6.5) |
The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study.
| score on a scale | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Score at Cycle 4 | -0.7 (-3.0 to 1.6) | -5.1 (-7.6 to -2.6) |
The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study.
| score on a scale | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Score at Cycle 6 | -0.9 (-3.4 to 1.6) | -5.9 (-8.6 to -3.2) |
The EQ-5D-5L comprises a descriptive module and a Visual Analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study.
| score on a scale | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Change From Baseline in the European Quality of Life 5 Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) at Cycle 4 | -0.4 ± 14.52 | -4.3 ± 12.92 |
The EQ-5D-5L comprises a descriptive module and a visual analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study.
| score on a scale | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| Change From Baseline in the EQ-5D-5L VAS at Cycle 6 | -0.2 ± 17.03 | -5.4 ± 13.09 |
An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).
| Participants | Arm A: Tislelizumab | Arm B: Sorafenib |
|---|---|---|
| TEAEs | 325 | 324 |
| SAEs | 104 | 91 |
Treatment-emergent anti-drug antibodies (ADA): participants who were ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA: participants who were ADA positive at baseline that was boosted to a 4-fold or higher-level following drug administration. ADA assessments were not performed for participants enrolled in the main study.
| Participants | Safety Run-In Sub-study |
|---|---|
| Treatment-Emergent ADA | 1 |
| Treatment-Boosted ADA | 0 |
Collected over All-cause mortality is reported from informed consent signing to first dose or discontinuation (Screening Period, 28 days) / from first dose to study completion (sub-study, Arm A and Arm B), up to approximately 65 months. AEs are reported from informed consent signing (SAEs only, in the Screening Period; 28 days) / from first dose of study drug to 30 days after last dose, new anticancer therapy, or study completion (up to 64 months in the sub-study, 61 months in Arm A, and 63 months in Arm B).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Run-In Sub-study | 7/10 (70%) | 1/10 (10%) | 8/10 (80%) |
| Arm A: Tislelizumab | 258/338 (76.3%) | 104/338 (30.8%) | 313/338 (92.6%) |
| Arm B: Sorafenib | 273/324 (84.3%) | 91/324 (28.1%) | 318/324 (98.1%) |
| Screening Period: All Enrolled Participants | 1/684 (0.1%) | 7/684 (1%) | — |
| Event | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Screening Period: All Enrolled Participants |
|---|---|---|---|---|
| PneumoniaInfections and infestations | 1/10 | 5/338 | 3/324 | 0/684 |
| VaricellaInfections and infestations | 1/10 | 0/338 | 0/324 | 0/684 |
| Pulmonary alveolar haemorrhageRespiratory, thoracic and mediastinal disorders | 1/10 | 0/338 | 0/324 | 0/684 |
| Aspartate aminotransferase increasedInvestigations | 0/10 | 6/338 | 5/324 | 0/684 |
| PyrexiaGeneral disorders | 0/10 | 3/338 | 5/324 | 0/684 |
| JaundiceHepatobiliary disorders | 0/10 | 3/338 | 5/324 | 0/684 |
| Alanine aminotransferase increasedInvestigations | 0/10 | 5/338 | 4/324 | 0/684 |
| Abdominal painGastrointestinal disorders | 0/10 | 2/338 | 4/324 | 0/684 |
| AscitesGastrointestinal disorders | 0/10 | 4/338 | 4/324 | 0/684 |
| General physical health deteriorationGeneral disorders | 0/10 | 1/338 | 4/324 | 0/684 |
| Event | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Screening Period: All Enrolled Participants |
|---|---|---|---|---|
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 1/10 | 1/338 | 203/324 | — |
| DiarrhoeaGastrointestinal disorders | 1/10 | 38/338 | 142/324 | — |
| Aspartate aminotransferase increasedInvestigations | 1/10 | 124/338 | 135/324 | — |
| PyrexiaGeneral disorders | 4/10 | 56/338 | 56/324 | — |
| Alanine aminotransferase increasedInvestigations | 0/10 | 93/338 | 111/324 | — |
| Blood bilirubin increasedInvestigations | 1/10 | 74/338 | 101/324 | — |
| AnaemiaBlood and lymphatic system disorders | 3/10 | 41/338 | 32/324 | — |
| FatigueGeneral disorders | 3/10 | 36/338 | 37/324 | — |
| Decreased appetiteMetabolism and nutrition disorders | 3/10 | 45/338 | 57/324 | — |
| RashSkin and subcutaneous tissue disorders | 3/10 | 40/338 | 56/324 | — |
Sub-study: Safety Analysis Set includes all participants in the safety run-in sub-study who received at least one dose of any study drug. Main Study: Intent-to-Treat Analysis Set includes all participants randomized in the main study.
| Age, Continuous(years) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| Mean | 71.70 ± 8.247 | 60.45 ± 12.528 | 59.51 ± 12.737 | 60.15 ± 12.652 |
| Sex: Female, Male(Participants) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| Female | 3 | 53 | 51 | 107 |
| Male | 7 | 289 | 281 | 577 |
| Race/Ethnicity, Customized(Participants) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| Asian | 10 | 255 | 250 | 515 |
| White | 0 | 71 | 73 | 144 |
| Not Reported | 0 | 9 | 6 | 15 |
| Unknown | 0 | 4 | 1 | 5 |
| Black or African American | 0 | 3 | 2 | 5 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Other | 0 | 0 | 0 | 0 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| 0 (Fully active) | 9 | 182 | 180 | 371 |
| 1 (Restricted but ambulatory) | 1 | 160 | 152 | 313 |
| Macrovascular Invasion(Participants) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| Present | 0 | 51 | 48 | 99 |
| Absent | 10 | 291 | 284 | 585 |
| Extrahepatic Spread(Participants) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| Present | 4 | 219 | 198 | 421 |
| Absent | 6 | 123 | 134 | 263 |
| Geographic Region(participants) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| Asia (excluding Japan) | 0 | 215 | 210 | 425 |
| Japan | 10 | 38 | 39 | 87 |
| European Union (EU)/United States (US) | 0 | 89 | 83 | 172 |
| Etiology(Participants) | Safety Run-In Sub-study | Arm A: Tislelizumab | Arm B: Sorafenib | Total |
|---|---|---|---|---|
| Hepatitis C Virus | 4 | 46 | 39 | 89 |
| Other | 6 | 296 | 293 | 595 |
Showing the first 100 of 122 sites across 11 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Dec 2017 to primary completion in Jul 2022, 54 months.
Results were first posted in Oct 2025, 3 years 3 months after primary completion. A results delay was requested in Jun 2023.
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 54 months is close to 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 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tislelizumab