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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 53 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Publications: details revised at 1 of 1 entry
  2. Interventions modifiedv4 Show 4 more changesShow less
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 36 words
    • Study title revised
    • Eligibility criteria expanded, about 1 word
  3. Study description revisedv3
  4. Enrollment target: 46 to 54v2 Show 5 more changesShow less
    • Interventions: Anti-VEGF (Drug), Immunotherapy (Drug), Local Therapy (Radiation) to Anti-VEGF (Drug), Immunotherapy (Drug), Local Therapy (Radiation), hepatic arterial infusion chemotherapy (HAIC) (Procedure)
    • Eligibility criteria expanded, about 298 words
    • Secondary endpoints revised (6)
    • Study description shortened, about 120 words
    • Study title revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07062055
Lead Sponsor Shandong Cancer Hospital and Institute
Conditions
(from sponsor)		 Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Oligometastases, Radiotherapy, Immunotherapy, Hepatic Artery Infusion Chemotherapy
Related terms Carcinoma, Hepatocellular
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov