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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Bevacizumab

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

62
Puerto Rico
Pan American Center for Oncology Trials, LLC00935, Rio Piedras Puerto Rico
United States
Arizona
University of Arizona Cancer Center85724, Tucson United States
California
UC San Diego Moores Cancer Center92093, La Jolla United States
University of Southern California-Keck School of Medicine -1975 Zonal Ave90089-5601, Los Angeles United States

Sponsors and collaborators

Genentech, Inc.

Lead sponsor