LOcoregional vs Systemic Therapy in Patients With BCLC Stage B HCC

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05537402
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab and bevacizumab — DRUG
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle and Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle
  • transarterial chemoembolization (TACE) or transarterial radioembolization (TARE — RADIATION
    TACE cycles occur every 8 weeks +/- 7 days OR TARE cycles occur every 12 weeks +/- 7 days

Study Details

The purpose of this research study is to compare the effectiveness and safety of two standard of care treatments in people who have been diagnosed with hepatocellular carcinoma (HCC).This research study is being done to compare atezolizumab/bevacizumab to locoregional therapy with either transarterial chemoembolization (TACE) or transarterial radioembolization (TARE).

Key Dates

Start date
Sep 27, 2023
Status verified
Jul 2025
Primary completion
Jun 6, 2025
Completion
Jun 6, 2025

Study Design

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

Arms

  • Experimental: Arm A: Atezolizumab and bevacizumab
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle. Atezolizumab will be administered first followed by bevacizumab, with a minimum of 5 minutes between dosing.
  • Active Comparator: Arm B: Locoregional therapy with TACE or TARE
    Patients will undergo locoregional therapy with TACE or TARE per investigator preference. TACE will be administered every 8 +/- 4 weeks; TARE will be administered every 12 +/- 4 weeks. Proportion of patients being treated with TARE will be capped at 50% of cohort at a protocol level. After 50% cap is reached, patients randomized to Arm B will be treated with TACE.

Primary Outcome Measure

Progression-free survival [ Time Frame: Baseline until date of first observed disease progression or death, assessed up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallasTexas75390-

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By research site
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas· Dallas, TX

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