NCT04102098

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 668 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Bevacizumab	Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Timeline

• Start date: 2019-12-31
• Primary completion: 2022-10-21
• Completion: 2026-05-15
• First posted: 2019-09-25
• Last updated: 2026-03-19
• Results posted: 2023-11-18

Locations

134 sites across 26 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Czechia, France, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study