A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Official Title

A Phase III, Multicentre, 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

Summary:

This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

Trial Description

Primary Outcome:

• Recurrence-Free Survival (RFS), as Determined by IRF

• Overall Survival (OS)
• RFS as Determined by the Investigator
• Time to Recurrence (TTR)
• RFS Rate at 24 and 36 Months, as Assessed by the IRF
• RFS Rate at 24 and 36 Months, as Assessed by the Investigator
• OS Rate at 24 and 36 Months
• Time to Extrahepatic Spread (EHS) or Macrovascular Invasion
• RFS in Pd-L1-High Subgroup
• Percentage of Participants With Adverse Events
• Serum Concentration of Atezolizumab
• Number of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab

View this trial on ClinicalTrials.gov