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

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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)

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)

Trial contacts and locations

42

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Central trial contact

Reference Study ID Number: ML42612 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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