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

Sponsor
Hoffmann-La Roche
Study ID
NCT04712643
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.
  • Becavizumab — DRUG
    Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
  • Transarterial chemoembolization (TACE) — DEVICE
    TACE will be performed by clinical demand.

Study Details

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.

Key Dates

Start date
Mar 12, 2021
Status verified
Apr 2026
Primary completion
Feb 1, 2029
Completion
Feb 1, 2029

Study Design

Enrollment
342 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: atezolizumab + bevacizumab + TACE
    Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
  • Active Comparator: Arm B: TACE alone
    Participants will receive on-demand transarterial chemoembolization.

Primary Outcome Measure

TACE Progression-Free Survival (TACE PFS) as Determined by Investigator [ Time Frame: Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months) ]

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