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NCT06096779

A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Genentech, Inc.
~30 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:AtezolizumabBevacizumab

At a glance

Recruiting sites
0 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Adverse Events (AEs)
Measured over Baseline through the end of the study (up to approximately 36 months)

Conditions

Hepatocellular Carcinoma

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Hepatocellular Carcinoma

NCT06096779

Where you'd take part

This study runs at 59 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michiganno site contact published

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsno site contact published

  • Bon Secours St. Mary's Hospital

    Richmond, Virginiano site contact published

  • California Liver Research Institute

    Pasadena, Californiano site contact published

  • Cedars Sinai Comprehensive Transplant Center

    West Hollywood, Californiano site contact published

  • Dayton VA Medical Center - NAVREF - PPDS

    Dayton, Ohiono site contact published

  • George Washington University- Medical Faculty Associates

    Washington D.C., District of Columbiano site contact published

  • Harbor UCLA Medical Center

    Torrance, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
Disease that is not amenable to curative surgical and/or locoregional therapies
No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to initiation of study treatment
Child-pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
Adequate hematologic and end-organ function
Life expectancy of at least 12 weeks
Female participants of childbearing potential must be willing to avoid pregnancy and egg donation
Absolute neutrophil count ≥1.0 x 10\^9 per liter (/L) (≥1000 per microliter \[/μL\]) without granulocyte colony-stimulating factor support
Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
Hemoglobin ≥ 80 grams per liter (g/L) (8 grams per deciliter \[g/dL\]) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN)
Serum bilirubin ≤ 3 × ULN
Creatinine clearance ≥ 50 milliliters per minute (mL/min) (calculated using the Cockcroft-gault formula)
Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
International normalized ratio (INR) ≤2.3

Exclusion

Pregnancy or breastfeeding
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
Treatment with systemic immunostimulatory agents
Treatment with systemic immunosuppressive medication
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
Inadequately controlled hypertension
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Participants who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation
Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded
Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Prior allogeneic stem cell or solid organ transplantation
Actively listed for liver transplantation
Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment
History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B
Diagnostic paracentesis is allowed. Therapeutic paracentesis: one large volume paracentesis prior to enrollment with diuretic controlled ascites is allowed.
Participants with ascites controlled on diuretics are allowed
History of spontaneous bacterial peritonitis within last 12 months

What this trial measures

  • Percentage of Participants With Adverse Events (AEs)Baseline through the end of the study (up to approximately 36 months)

    An AE is any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) in Cohorts A and B.