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A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-Pd-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Protocol No
GENENTECH-WO41535-IMBRAVE050
Principal Investigator
Ben George
Phase
III
Summary
The purpose of this study is to compare the effects, good or bad, of Atezolizumab plus Bevacizumab versus observation (not receiving any treatment) on patients with completely resected or ablated HCC who are at high risk for disease recurrence. In this study, you will get either Atezolizumab plus Bevacizumab or no treatment. Atezolizumab is an antibody (a protein similar to the ones produced by your body's immune system) that blocks the programmed death-ligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the body's natural immune response, but tumors can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD-L1 pathway, Atezolizumab may help your immune system stop or reverse the growth of tumors. Atezolizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of bladder cancer, lung cancer, and triple negative breast cancer. Bevacizumab is an antibody that slows the growth of new blood vessels and may help your body stop the growth of tumors. It has been approved for treating certain advanced cancers such as colorectal and non-small cell lung cancer. For this clinical trial, Atezolizumab and Bevacizumab are experimental drugs, which means the FDA has not approved either drug for the treatment of HCC after surgical resection or ablation. We don't know if this study will help you. Your condition may get better but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for hepatocellular carcinoma in the future.
Description
The purpose of this study is to compare the effects, good or bad, of Atezolizumab plus
Bevacizumab versus observation (not receiving any treatment) on patients with completely
resected or ablated HCC who are at high risk for disease recurrence.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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