A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
Genentech, Inc.
Summary
The purpose of this study is to assess the safety 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.
Description
This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic HCC who have Child-pugh B7 or B8 liver cirrhosis and have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAtezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
- DrugBevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) by IV infusion on Day 1 of each 21-day cycle.
Locations (61)
- University of Arizona Cancer CenterTucson, Arizona
- UC San Diego Moores Cancer CenterLa Jolla, California
- University of Southern California-Keck School of Medicine -1975 Zonal AveLos Angeles, California
- University of Southern CaliforniaNewport Beach, California
- University of California Irvine Medical CenterOrange, California
- California Liver Research InstitutePasadena, California