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Brief Title: A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
Official Title: A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
Study ID: NCT06096779
Brief 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.
Detailed Description: This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (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 and efficacy of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Southern California-Keck School of Medicine -1975 Zonal Ave, Los Angeles, California, United States
University of Southern California; Oncology/Hematology, Newport Beach, California, United States
University of California Irvine Medical Center, Orange, California, United States
University of California Davis Medical Center, Sacramento, California, United States
Hartford Healthcare Cancer Institute at Hartford Hospital, Hartford, Connecticut, United States
LSU Health Baton Rouge; North Clinic, Baton Rouge, Louisiana, United States
Our Lady of the Lake Physician Group, Baton Rouge, Louisiana, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Maine, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey at University Hospital, Newark, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Long Island Heart Associates, Mineola, New York, United States
NYU Langone Medical Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Kaiser Permanente Westside Medical Center, Hillsboro, Oregon, United States
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS, Pittsburgh, Pennsylvania, United States
The West Clinic (East Campus), Germantown, Tennessee, United States
Liver Institute at Methodist Dallas, Dallas, Texas, United States
Kelsey Research Foundation, Houston, Texas, United States
Maryview Hospital, Inc., Newport News, Virginia, United States
Bon Secours St. Mary's Hospital, Richmond, Virginia, United States
Benaroya Research Institute at Virginia Mason, Seattle, Washington, United States
Pan American Center for Oncology Trials, LLC, Rio Piedras, , Puerto Rico
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR