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

• Status: Recruiting
• Trial end date: 2026-11-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-Pugh B7 or B8 cirrhosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Atezolizumab; Bevacizumab

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 patients

• 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 RECIST v1.1

• 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

General Exclusion Criteria:

• Pregnancy or breastfeeding

• Prior treatment with 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

• History of malignancy other than HCC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

• 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

• 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

• History of hepatic encephalopathy requiring hospitalization or treatment escalation within 6 months prior to study treatment, or any continued symptoms of encephalopathy despite medical management

• History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS)

• History of ascites requiring therapeutic paracentesis over the last 3 months

• History of spontaneous bacterial peritonitis within last 12 months