A 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 Ablatio

Phase 1

• Conditions: High-risk hepatocellular carcinoma (HCC); MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504303-86-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

Participants with a first diagnosis of HCC who have undergone either curative resection or ablation (RFS or MWA only) within 4-12 weeks prior to randomization, High risk for HCC recurrence after resection or ablation, Full recovery from surgical resection or ablation within 4 weeks prior to randomization, Absence of MVI (Vp3 or Vp4), ECOG Performance Status of 0 or 1, Child-Pugh Class A status

Exclusion Criteria

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC, Evidence of residual, recurrent, or metastatic disease at randomization, On the waiting list for liver transplant, History of hepatic encephalopathy, Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization, Have received more than 1 cycle of adjuvant TACE following surgical resection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillance on the basis of recurrence-free survival (RFS) as determined by an IRF;Secondary Objective: To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillance on the basis of overall survival (OS), RFS after randomization as determined by the investigator and by an Independent Review Facility (IRF), time to recurrence (TTR), IRF-assessed RFS and investigator-assessed RFS rate after randomization and OS rate at 24 months and 36 months, Time to extrahepatic spread or macrovascular invasion after randomization, To evaluate the safety of atezolizumab plus bevacizumab compared with active surveillance, To characterize the PK profile of atezolizumab when given in combination with bevacizumab, To evaluate the immune response to atezolizumab;Primary end point(s): 1. Independent Review Facility (IRF)-assessed recurrence-free survival (RFS)