A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04102098
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Study Details

This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

Key Dates

Start date
Dec 31, 2019
Status verified
Mar 2026
Primary completion
Oct 21, 2022
Completion
May 15, 2026

Study Design

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

Arms

  • Experimental: Arm A (atezolizumab plus bevacizumab)
    Participants will receive Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
  • No Intervention: Arm B (active surveillance)
    Active surveillance of participants.

Primary Outcome Measure

Recurrence-Free Survival (RFS), as Determined by IRF [ Time Frame: Baseline up to approximately 33 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Los AngelesLos AngelesCalifornia90027-
Mercy Medical CenterBaltimoreMaryland21202-
Henry Ford Health SystemDetroitMichigan48202-
Columbia University Medical CenterNew YorkNew York10032-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
The University of Texas Southwestern Medical Center at DallasDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer Inst.SeattleWashington98104-

Find similar trials in Los Angeles, CA

By research site
Kaiser Permanente Los Angeles· Los Angeles, CAMercy Medical Center· Baltimore, MDHenry Ford Health System· Detroit, MIColumbia University Medical Center· New York, NYThomas Jefferson University· Philadelphia, PAThe University of Texas Southwestern Medical Center at Dallas· Dallas, TX

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