Home › Trials › NCT06096779

Evaluating Atezolizumab with or without Bevacizumab for liver cancer treatment

A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Phase 2 Interventional Genentech, Inc. · NCT06096779

This study is testing if a combination of two cancer drugs, atezolizumab and bevacizumab, is safe for people with advanced liver cancer who have certain liver conditions.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment30 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. Industry-sponsored
Drugs / interventionsatezolizumab, bevacizumab
Locations61 sites (Tucson, Arizona and 60 other locations)
Trial IDNCT06096779 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label, multicohort study aims to assess the safety of atezolizumab alone or in combination with bevacizumab in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 cirrhosis. Participants must have received no prior systemic therapy for their condition and have measurable disease. The study will evaluate two cohorts: one receiving both drugs and the other receiving only atezolizumab, focusing on their safety profiles.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable HCC and Child-Pugh B7 or B8 cirrhosis who have not received prior systemic treatment.

Not a fit: Patients with curable liver cancer or those who have previously undergone systemic therapy for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new first-line therapy option for patients with advanced liver cancer and cirrhosis.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in liver cancer, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
General Inclusion Criteria:

* 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

General Exclusion Criteria:

* 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

Where this trial is running

Tucson, Arizona and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular CarcinomaCirrhosisLiver CancerLiver TumorChild-pugh BAtezolizumabBevacizumabImmune Checkpoint Inhibitor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.