A Clinical Study Evaluating HAIC Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Study ID
- NCT07119931
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab — DRUGIparomlimab and Tuvonralimab Injection(Q1706): 7.5 mg/kg, q3w, given on Day 1 (±7 days) of each 21-day cycle; Bevacizumab: 7.5 mg/kg, q3w, administered on Day 1 (±7 days) of each 21-day cycle; HAIC:Oxaliplatin 85 mg/m² via arterial infusion over 2-3 hours, Levoleucovorin 200 mg/m² via arterial infusion over 1-2 hours, 5-Fluorouracil 400 mg/m² via arterial bolus injection, followed by continuous arterial infusion of 2400 mg/m² over 23 hours, q3w, with the treatment interval not exceeding 4 weeks.
Study Details
Major Objectives To evaluate the efficacy of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab as a conversion therapy in patients with potentially resectable HCC, assessed by the conversion resection rate.
Key Dates
- First listed
- Aug 13, 2025
- Start date
- Sep 10, 2025
- Status verified
- Aug 2025
- Primary completion
- Dec 30, 2027
- Completion
- Dec 30, 2029
Study Design
- Enrollment
- 34 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumablparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab
Primary Outcome Measure
Conversion resection rate [ Time Frame: up to 12 month ]
Central Contacts
- Huikai Li, Doctor+8618526812877
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