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 — DRUG
    Iparomlimab 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 bevacizumab
    lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab

Primary Outcome Measure

Conversion resection rate [ Time Frame: up to 12 month ]

Central Contacts

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