Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH)

The goal of this clinical trial is to compare the safety and efficacy of sequential Transarterial Chemoembolization (TACE) and Stereotactic body radiation therapy (SBRT) versus Y90-radioembolisation (SIRT), followed by systemic therapy in patients with large, locally advanced, unresectable Hepatocellular carcinoma (HCC). The main question it aims to answer is whether Sequential TACE-SBRT potentially gives longer Progression-free survival (PFS) benefit with similar toxicities as compared with Y90 SIRT. Participants will be recruited via multidisciplinary meetings (MDTs) with hepatobiliary surgeons, medical hepatologists and radiologists with consistent, strict considerations on eligibility and treatment alternatives. Eligible patients will be randomized in 1:1 ratio to received one of the two treatment arms.

NCT Number	NCT07293468
Lead Sponsor	Tuen Mun Hospital Collaborators: Queen Mary Hospital, Hong Kong, The University of Hong Kong, The University of Hong Kong-Shenzhen Hospital
Conditions	Hepatocellular Carcinoma (HCC)
Enrollment	106 participants
Start Date	2024-04-01
Primary Completion	2034-03-31 (estimated)
Study Completion	2034-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-09