Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)
NCT05883644 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111
Last updated 2026-04-30
Summary
This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.
Conditions
Interventions
- DRUG
-
Participants will receive 1500 mg at Day 1 and later receive as monotherapy starting at Week 4 for every 4 weeks through IV infusion
- DRUG
-
Tremelimumab
Participants will receive single dose of 300 mg through IV infusion at Day 1
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Stephen Chan, MD · Department of Clinical Oncology, Chinese University of Hong Kong
-
Lorenza Rimassa, MD · Humanitas Cancer Centre, IRCCS Humanitas Research Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-27
- Primary Completion
- 2026-03-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
- France
- Germany
- Hong Kong
- Italy
- Japan
- Singapore
- South Korea
- Spain
- Vietnam
Study Locations
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