A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma
NCT05908786 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2025-12-11
Summary
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.
Conditions
- Carcinoma, Hepatocellular
Interventions
- DRUG
-
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1.
- DRUG
-
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1.
- DRUG
-
Tiragolumab
Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1.
- DRUG
-
Tobemstomig
Tobemstomig will be administered at a dose of 600 mg by IV infusion on Day 1
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-05
- Primary Completion
- 2025-08-27
- Completion
- 2025-11-13
- FDA Drug
- Yes
Countries
- United States
- Austria
- France
- Germany
- New Zealand
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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