Last reviewed · How we verify
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases
This multicenter, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining bevacizumab plus iparomlimab/tuvonralimab with hepatic artery infusion chemotherapy (HAIC) 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.
Details
| Lead sponsor | Shandong Cancer Hospital and Institute |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 54 |
| Start date | Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Jul 25 2029 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Hepatocellular Carcinoma
- Portal Vein Tumor Thrombus
- Oligometastases
- Radiotherapy
- Immunotherapy
- Hepatic Artery Infusion Chemotherapy
Interventions
- Anti-VEGF
- Immunotherapy
- Local Therapy
- hepatic arterial infusion chemotherapy (HAIC)
Countries
China