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

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Atezolizumab; Drug: Becavizumab; Device: Transarterial chemoembolization (TACE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04712643

ML42612

Details and patient eligibility

About

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 at high risk of poorer outcome following TACE treatment.

Enrollment: 342 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Vp3/4 and hepatic vein tumor thrombus (HVTT)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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342 participants in 2 patient groups

Arm A: atezolizumab + bevacizumab + TACE

Experimental group

Description:

Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.

Treatment:

Device: Transarterial chemoembolization (TACE)

Drug: Becavizumab

Drug: Atezolizumab

Arm B: TACE alone

Active Comparator group

Description:

Participants will receive on-demand transarterial chemoembolization.

Treatment:

Device: Transarterial chemoembolization (TACE)