A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

• Status: Recruiting
• Trial end date: 2027-02-26
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are unsuitable for curative therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Atezolizumab

Criteria

Inclusion Criteria:

• Confirmed diagnosis of HCC by histology/ cytology or clinical criteria

• Eligible for TACE treatment

• No prior systemic therapy for HCC, especially immunotherapy

• No prior locoregional therapy to the target lesion(s)

• At least one measurable untreated lesion

• ECOG Performance Status of 0-1

• Child-Pugh class A

Exclusion Criteria:

• Evidence of macrovascular invasion (MVI)

• Evidence of extrahepatic spread (EHS)

• Being a candidate for curative treatments

• Any condition representing a contraindication to TACE as determined by the investigators

• Active or history of autoimmune disease or immune deficiency

• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding

• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment

• Evidence of bleeding diathesis or significant coagulopathy