NCT05537402

LOcoregional vs Systemic Therapy in Patients With BCLC Stage B HCC

Phase II Multi-center Randomized, Open-label, Trial of Atezolizumab and Bevacizumab vs Locoregional Therapy (Transarterial Chemoembozliation or Radioembolization) as First-line Therapy in Patients With Large Intermediate-stage Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

To evaluate the efficacy and safety of atezolizumab and bevacizumab compared to locoregional therapy (TACE or TARE) in patients with intermediate-stage HCC. The primary outcome is progression-free survival, which will be compared between two arms using stratified log-rank tests, adjusting the effect of stratification variables between two study arms. Cox regression analysis will be done to see if there are significant differences in PFS, controlling for the effects of confounding variables between the two study arms.

Conditions

• Hepatocellular Carcinoma

Interventions

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

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-06-06
• Completion: 2025-06-06
• First posted: 2022-09-13
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study