An observational study in Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma Non-Resectable, sponsored by Assiut University. Not yet recruiting at 4 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Assiut University · Observational
Among 19 studies in Carcinoma, Hepatocellular by Assiut University — 10 open to participants now, 10 under way, none of them phase 3. Carcinoma, Hepatocellular · Assiut University.
Among the 19 studies in Carcinoma, Hepatocellular by Assiut University, this one is the 2nd largest by planned enrollment of the 16 observational ones, is one of 2 that started in 2026, is one of 16 observational ones, and was the 19th registered.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 294 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →10 of the 19 studies in Carcinoma, Hepatocellular by Assiut University are open now, in 1 country. Each count lists the studies.
Of the 736 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; 30 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2026.
Median enrollment 75 across the 3 interventional studies, 100 across the 16 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
3 of the studies in Carcinoma, Hepatocellular by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07667608Assiut UniversityUltrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings | 2027-08-10 |
| NCT07904494Assiut UniversityImmune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma | 2027-10-01 |
| NCT07183566Assiut UniversityCT Volume Measurement of Hepatocellular Carcinoma | 2027-10-01 |
Among the 19 studies in Carcinoma, Hepatocellular by Assiut University, from their registry updates:
The goal of this observational study is to evaluate how well first-line immunotherapy works and investigate its association with immune-related adverse events (irAEs) in Egyptian adults with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery.
The main questions this study aims to answer are:
The study will also explore whether routine blood markers, including eosinophil counts and markers of inflammation and nutritional status, are associated with treatment outcomes and the development of immune-related side effects. Changes in liver function and patients' health-related quality of life will also be evaluated.
Approximately 294 patients receiving first-line immunotherapy as part of their routine medical care will be included. Patients may receive atezolizumab plus bevacizumab or durvalumab plus tremelimumab, as prescribed by their treating physicians. Researchers will not assign treatments or change patients' medical care.
The study will include a review of existing medical records and prospective follow-up of eligible patients. Researchers will:
Researchers will compare treatment outcomes between patients who develop irAEs and those who do not, while taking into account when these side effects occur.
This multicenter, ambispective (retrospective and prospective) observational cohort study aims to evaluate the therapeutic efficacy of first-line immunotherapy and investigate its association with immune-related adverse events (irAEs) in Egyptian patients with unresectable hepatocellular carcinoma (uHCC).
The study will be conducted at four specialized healthcare institutions in Egypt: Al-Rajhi University Hospital, Assiut University; El-Mabaraa Health Insurance Hospital, Assiut; Menoufia Cancer Institute; and the National Liver Institute, Menoufia University.
The study population consists of adult patients with uHCC receiving first-line immune checkpoint inhibitor-based therapy (such as atezolizumab plus bevacizumab or durvalumab plus tremelimumab) in routine clinical practice. Treatment decisions and clinical management remain entirely at the discretion of the treating physicians, without any investigator-directed treatment allocation.
The retrospective component will extract baseline clinical characteristics, treatment exposure, adverse events, laboratory findings, radiological assessments, and available clinical outcomes from the medical records of eligible patients who initiated immunotherapy before study commencement. Newly eligible patients will be enrolled and followed prospectively.
A primary focus of the study is to evaluate treatment safety through the continuous documentation of irAEs, emphasizing their occurrence, type, timing, severity (using CTCAE v5.0), and management. Crucially, the association between irAEs and therapeutic efficacy will be investigated using appropriate statistical methods that account for the timing of irAE onset, including time-dependent survival analyses to minimize immortal time bias.
An exploratory comparative analysis will be conducted between patients receiving first-line atezolizumab plus bevacizumab and those receiving durvalumab plus tremelimumab (STRIDE). Comparisons will include therapeutic efficacy, assessed by overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as treatment safety, including the incidence and severity of immune-related and non-immune-related adverse events. Differences in liver function, inflammatory and immunonutritional biomarkers, and health-related quality of life may also be explored where sufficient data are available. Relevant baseline clinical differences between treatment groups will be considered using appropriate statistical adjustment methods when feasible.
Beyond irAEs, exploratory analyses will investigate the potential prognostic and predictive roles of peripheral blood eosinophil counts and selected systemic inflammatory and immunonutritional markers. These include the absolute eosinophil count (AEC), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), and prognostic nutritional index (PNI). Longitudinal changes in these markers, alongside hepatic function assessments (Child-Pugh and ALBI scores), will be evaluated to explore factors associated with hepatic deterioration and treatment outcomes.
Health-related quality of life (HRQoL) will be assessed among prospectively enrolled patients using the Arabic versions of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the hepatocellular carcinoma-specific module (EORTC QLQ-HCC18). Assessments are planned at baseline and every three months during follow-up, with additional assessments at disease progression or treatment discontinuation when feasible. Longitudinal changes in global health status, functional domains, and symptom scores will be evaluated. Clinically meaningful deterioration in HRQoL may also be explored when sufficient follow-up data are available.
Statistical analyses will utilize regression models and survival analysis (Kaplan-Meier and Cox proportional hazards models). As an observational study, research activities at each participating center will be conducted strictly in accordance with applicable ethical approvals and institutional guidelines, without modifying routine clinical care.
The study population will include Egyptian adults (≥18 years) with unresectable hepatocellular carcinoma (BCLC stage B or C) receiving first-line immune checkpoint inhibitor-based combination therapy in routine clinical practice. Eligible regimens currently include atezolizumab plus bevacizumab and durvalumab plus tremelimumab (STRIDE). Other approved standard-of-care ICI-based combinations adopted during the study period may also be included, in accordance with the approved protocol. Patients will be identified at Al-Rajhi University Hospital (Assiut University), El-Mabaraa Health Insurance Hospital (Assiut), Menoufia Cancer Institute and the National Liver Institute (Menoufia University). Both retrospectively identified and prospectively enrolled patients meeting the eligibility criteria will be included.
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.
Systemic therapy eligibility: Eligible to receive systemic immunotherapy-based combination regimens, as per institutional protocol at the time of treatment initiation, including:
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 line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
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.
Drug pages: Atezolizumab · Bevacizumab
Patients receive atezolizumab (1,200 mg intravenously) plus bevacizumab (15 mg/kg intravenously) every 3 weeks as first-line treatment for unresectable hepatocellular carcinoma, according to routine clinical practice. Treatment selection, administration, and modifications are determined by the treating physician and are not assigned by the study investigators.
Also known as: Tecentriq, Avastin, Atez/Bev
Drug pages: Durvalumab · Tremelimumab
Patients receive a single intravenous dose of tremelimumab (300 mg) combined with durvalumab (1,500 mg) on day 1, followed by durvalumab (1,500 mg intravenously) every 4 weeks, according to routine clinical practice. Treatment selection, administration, and modifications are determined by the treating physician and are not assigned by the study investigators.
Also known as: STRIDE, Imfinzi, Imjudo
Odds Ratio for Objective Tumor Response According to Immune-Related Adverse Event Status (RECIST 1.1)
The odds ratio (OR) of objective tumor response in patients with versus without immune-related adverse events (irAEs) will be estimated, with 95% confidence intervals. Objective response is defined as a best overall response of complete response (CR) or partial response (PR), assessed by CT or MRI according to RECIST version 1.1. irAEs will be identified through clinical assessment and medical record review, with their dates of onset documented. The timing of irAE occurrence will be considered in the prespecified association analysis to minimize time-related bias. The reported association measurث will be an odds ratio (unitless).
Time frame: From the first dose of immunotherapy until disease progression, death, or last evaluable tumor assessment, assessed up to 12 months.
Hazard Ratio for Overall Survival According to Time-Varying Immune-Related Adverse Event Status
The hazard ratio (HR) for all-cause mortality associated with immune-related adverse event (irAE) occurrence will be estimated using time-dependent Cox proportional hazards regression, with 95% confidence intervals. Overall survival (OS) is defined as the time from the first dose of immunotherapy to death from any cause, measured in months. Patients alive at the last known follow-up will be censored. irAEs will be identified through clinical assessment and medical record review, with their dates of onset documented. irAE status will be modeled as a time-varying exposure, classified as unexposed before the first irAE onset and exposed thereafter. The reported association measure will be a hazard ratio (unitless)
Time frame: From the first dose of immunotherapy until death from any cause or last known follow-up, assessed up to 12 months.
Percentage of Patients Experiencing at Least One Immune-Related Adverse Event (irAE)
The percentage of patients experiencing at least one immune-related adverse event (irAE) following initiation of first-line immunotherapy will be determined. irAEs will be identified through clinical assessment and medical record review, including available laboratory and radiological findings, after consideration of alternative causes. Events will be classified and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Each patient will be counted once regardless of the number of irAEs experienced. The outcome will be reported as the percentage of patients with at least one irAE.
Time frame: From the first dose of immunotherapy until death or last available safety assessment, assessed up to 12 months.
Percentage of Patients Experiencing Grade 3 or Higher Immune-Related Adverse Events
The percentage of patients experiencing at least one severe immune-related adverse event (irAE), defined as Grade 3 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, will be determined. Severity will be assessed using the maximum documented CTCAE grade for each irAE. Each patient will be counted once if at least one Grade 3 or higher irAE occurs. The outcome will be reported as the percentage of patients with Grade 3 or higher irAEs.
Time frame: From the first dose of immunotherapy until death or the last available safety assessment, assessed up to 12 months.
Hazard Ratio for Progression-Free Survival According to Time-Varying Immune-Related Adverse Event Status
The hazard ratio (HR) for disease progression or death associated with immune-related adverse event (irAE) occurrence will be estimated using time-dependent Cox proportional hazards regression, with 95% confidence intervals. Progression-free survival (PFS) is defined as the time in months from the first dose of immunotherapy to the first documented radiological disease progression or death from any cause, whichever occurs first. Radiological progression will be assessed using CT or MRI according to RECIST version 1.1 in patients with adequate evaluable imaging. Patients without documented progression or death will be censored at their last adequate tumor assessment. irAE status will be modeled as a time-varying exposure based on the date of first irAE onset. The reported association measure will be a hazard ratio (unitless).
Time frame: From the first dose of immunotherapy until first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months.
Odds Ratio for Disease Control According to Immune-Related Adverse Event Status (RECIST 1.1)
The odds ratio (OR) for achieving disease control in patients with versus without immune-related adverse events (irAEs) will be estimated, with 95% confidence intervals. Disease control is defined as a best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by CT or MRI according to RECIST version 1.1. irAEs will be identified through clinical assessment and medical record review, with their dates of onset documented. The timing of irAE occurrence will be considered in the prespecified association analysis to minimize time-related bias. The reported association measure will be an odds ratio (unitless).
Time frame: From the first dose of immunotherapy until disease progression, death, or last evaluable tumor assessment, assessed up to 12 months.
Percentage of Patients Experiencing at Least One Non-Immune-Related Adverse Event
The percentage of patients experiencing at least one non-immune-related adverse event following initiation of first-line immunotherapy-based treatment will be determined. Events will be identified through clinical assessment and medical record review and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Events may include hypertension, bleeding, and thromboembolic complications when classified as non-immune-related. Each patient will be counted once regardless of the number of qualifying events. The outcome will be reported as the percentage of patients (%).
Time frame: From the first dose of immunotherapy until death or last available safety assessment, assessed up to 12 months.
Change From Baseline in Albumin-Bilirubin (ALBI) Score During Immunotherapy
Changes in liver function will be assessed using the albumin-bilirubin (ALBI) score, calculated from serum albumin and total bilirubin concentrations. ALBI score will be calculated as (0.66 × log10 total bilirubin \[µmol/L\]) - (0.085 × serum albumin \[g/L\]). Change from baseline will be calculated as the ALBI score at each available follow-up assessment minus the baseline ALBI score. Higher ALBI scores indicate worse liver function. Results will be reported as changes in the unitless ALBI score.
Time frame: At baseline and during each treatment cycle until disease progression, death, or last available liver function assessment, assessed up to 12 months.
Change From Baseline in Child-Pugh Score During Immunotherapy
Changes in hepatic functional status will be assessed using the Child-Pugh score, based on serum bilirubin, serum albumin, international normalized ratio (INR), ascites, and hepatic encephalopathy. The total score ranges from 5 to 15 points, with higher scores indicating worse liver function. Change from baseline will be calculated as the Child-Pugh score at each evaluable follow-up assessment minus the baseline score. Results will be reported in Child-Pugh score points.
Time frame: At baseline and each available treatment cycle until disease progression, death, or the last available liver function assessment, up to 12 months.
Change From Baseline in EORTC QLQ-C30 Summary Score
The EORTC QLQ-C30 Summary Score will be calculated using the validated Arabic questionnaire. It combines 13 scales: five functional scales, three multi-item symptom scales, and five single-item symptom scales. Symptom scores will be reversed, and the mean of the 13 scales will be calculated according to EORTC scoring guidelines. The score ranges from 0 to 100, with higher scores indicating better overall quality of life. Change from baseline will be reported in points.
Time frame: At baseline and every 3 months during follow-up, with additional assessment at disease progression or treatment discontinuation when feasible, up to 12 months.
Change From Baseline in EORTC QLQ-HCC18 Index Score
HCC-specific quality of life will be assessed using the validated Arabic EORTC QLQ-HCC18 questionnaire. It includes six multi-item scales (fatigue, jaundice, body image, nutrition, pain, and fever) and two single items (sexual interest and abdominal swelling). Each scale will be transformed to 0-100 according to EORTC scoring guidelines. The HCC18 Index Score is the mean of the eight scale scores, ranging from 0 to 100. Higher scores indicate greater symptom burden and worse quality of life. Change from baseline will be reported in points.
Time frame: At baseline and every 3 months during follow-up, with additional assessment at disease progression or treatment discontinuation when feasible, up to 12 months.
Change From Baseline in Absolute Eosinophil Count (AEC) During Immunotherapy
Longitudinal changes in peripheral blood absolute eosinophil count (AEC) will be assessed using complete blood count with differential leukocyte count. AEC will be recorded in cells/µL at baseline and at available follow-up assessments. Change from baseline will be calculated as the follow-up AEC minus the baseline AEC. Results will be reported in cells/µL.
Time frame: At baseline and during available treatment cycles (approximately every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or the last available laboratory assessment, up to 12 months.
Exploratory Real-World Comparison of Effectiveness and Safety Between First-Line Immunotherapy Regimens in Egypt
An exploratory comparison between atezolizumab plus bevacizumab and tremelimumab plus durvalumab (STRIDE) will be performed among Egyptian patients with unresectable hepatocellular carcinoma receiving first-line immunotherapy in routine clinical practice. Clinical outcomes will include overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and the incidence and severity of adverse events. Baseline clinical differences between treatment groups will be considered in adjusted comparative analyses where feasible
Time frame: From the first dose of immunotherapy until the applicable outcome event or last available assessment, including death for OS and disease progression or death for PFS, assessed up to 12 months.
Change From Baseline in Prognostic Nutritional Index (PNI) During Immunotherapy
Longitudinal changes in the prognostic nutritional index (PNI) will be evaluated using serum albumin concentrations and absolute lymphocyte counts obtained from routine laboratory assessments. PNI will be calculated as \[10 × serum albumin (g/dL)\] + \[0.005 × absolute lymphocyte count (cells/µL)\]. Change from baseline will be calculated as the follow-up PNI minus the baseline PNI. Higher PNI values generally indicate better nutritional and immunological status. Results will be reported as changes in PNI index points.
Time frame: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.
Change From Baseline in Neutrophil-to-Lymphocyte Ratio (NLR) During Immunotherapy
Longitudinal changes in the neutrophil-to-lymphocyte ratio (NLR) will be evaluated using absolute neutrophil and lymphocyte counts obtained from routine complete blood count assessments. NLR will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count, with both counts expressed in the same units. Change from baseline will be calculated as the follow-up NLR minus the baseline NLR. Higher values indicate a greater relative neutrophil predominance. Results will be reported as changes in the unitless NLR.
Time frame: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.
Change From Baseline in Platelet-to-Lymphocyte Ratio (PLR) During Immunotherapy
Longitudinal changes in the platelet-to-lymphocyte ratio (PLR) will be evaluated using platelet and absolute lymphocyte counts obtained from routine complete blood count assessments. PLR will be calculated by dividing the platelet count by the absolute lymphocyte count, with both counts expressed in the same units. Change from baseline will be calculated as the follow-up PLR minus the baseline PLR. Higher values indicate greater platelet predominance relative to lymphocytes. Results will be reported as changes in the unitless PLR.
Time frame: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.
Change From Baseline in Systemic Immune-Inflammation Index (SII) During Immunotherapy
Longitudinal changes in the systemic immune-inflammation index (SII) will be evaluated using platelet, absolute neutrophil, and absolute lymphocyte counts obtained from routine complete blood count assessments. SII will be calculated as \[platelet count × absolute neutrophil count\] / absolute lymphocyte count, with all counts expressed in 10⁹/L. Change from baseline will be calculated as the follow-up SII minus the baseline SII. Higher values indicate greater platelet-neutrophil predominance relative to lymphocytes. Results will be reported as changes in SII values (10⁹/L).
Time frame: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.
Change From Baseline in Systemic Inflammation Response Index (SIRI) During Immunotherapy
Longitudinal changes in the systemic inflammation response index (SIRI) will be evaluated using absolute neutrophil, monocyte, and lymphocyte counts obtained from routine complete blood count assessments. SIRI will be calculated as \[absolute neutrophil count × absolute monocyte count\] / absolute lymphocyte count, with all counts expressed in 10⁹/L. Change from baseline will be calculated as the follow-up SIRI minus the baseline SIRI. Higher values indicate greater neutrophil-monocyte predominance relative to lymphocytes. Results will be reported as changes in SIRI values (10⁹/L).
Time frame: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.
Plan to share: No — There is currently no plan to share individual participant-level data outside the study team. The study involves sensitive clinical data collected across multiple institutions, and any future data sharing would require appropriate ethical and institutional approvals and data protection safeguards. Study findings will be disseminated in aggregate form through scientific publications and presentations.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
Of 302 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 114. This study's planned 11 months is below that.
Counting every sponsor, half of 351 studies reached it within 51 months; a quarter within 32 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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