Phase 2Recruiting
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases
Bevacizumab Plus Iparomlimab/Tuvonralimab With Hepatic Artery Infusion Chemotherapy Followed by Surgical Resection or Stereotactic Body Radiotherapy in Patients With BCLC Stage C Hepatocellular Carcinoma With Thrombus and/or Extrahepatic Oligometastases (BITS-TO-HCC): Study Protocol of a Prospective, Single- Center, Single-Arm, Phase II Study
- Sponsor
- Shandong Cancer Hospital and Institute (Academic or other)
- Enrolment
- 54 planned
- 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); Surgical Resection
- Ages
- adults, older adults
- Registry
- NCT07062055
Full record on ClinicalTrials.gov
From the registry
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 multidisciplinary team (MDT) evaluation for surgical resection or 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), and evaluate the conversion rate to surgical resectability, 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.
Primary outcomes
- Progression-free survival (PFS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered
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