NCT07119931

A Clinical Study Evaluating HAIC Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)

A Single-Arm, Single-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This single-center, single-arm, phase II clinical study aims to evaluate the efficacy and safety of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab in patients with potentially resectable HCC. The study consists of four periods: screening, treatment, safety follow-up, and survival follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab	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.

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-12-30
• Completion: 2029-12-30
• First posted: 2025-08-13
• Last updated: 2025-08-13