BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases

This single-center, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining hepatic artery infusion chemotherapy (HAIC, for up to 4 cycles) with iparomlimab/tuvonralimab plus bevacizumab followed by stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and local control rate (LCR), as well as maintaining quality of life (QoL). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.

NCT Number	NCT07062055
Lead Sponsor	Shandong Cancer Hospital and Institute
Conditions	Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Oligometastases, Radiotherapy, Immunotherapy, Hepatic Artery Infusion Chemotherapy
Enrollment	54 participants
Start Date	2025-07-25
Primary Completion	2028-07-25 (estimated)
Study Completion	2029-07-25 (estimated)
Updated on ClinicalTrials.gov	2026-05-08