NCT07128251

A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.

Detailed description

This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria. After signing the informed consent form (ICF) and passing screening, subjects will undergo the first TACE procedure. Conventional TACE (cTACE) will be performed using lipiodol as the embolic agent and epirubicin as the chemotherapeutic agent. Study drug administration will commence at least 2 weeks after the first TACE: Iparomlimab and Tuvonralimab Injection \[7.5 mg/kg, intravenous infusion, Day 1 (D1) of each cycle, every 21 days (Q3W)\] combined with Bevacizumab Injection \[15 mg/kg, intravenous infusion, D1, Q3W\]. Each treatment cycle is 21 days (Q3W). On-demand TACE therapy will be administered concurrently, with a maximum of 4 TACE sessions permitted. The interval between consecutive TACE sessions must be at least 4 weeks. Bevacizumab Injection must be withheld for at least 2 days prior to any TACE procedure. Study drug administration must resume at least 2 weeks after any TACE procedure. Subjects must have fully recovered from TACE prior to receiving study drugs. Investigators may delay dosing based on toxicity recovery, but study drugs should be administered as soon as feasible once requirements are met. Treatment will continue until the investigator assesses no further clinical benefit for the subject, the subject experiences intolerable toxicity, withdraws consent, or meets other protocol-specified criteria for treatment discontinuation (whichever occurs first). Safety Visits: After enrollment, safety assessments will be performed 2 weeks (14 ± 3 days) after each TACE procedure and on D1 of each study drug cycle prior to drug administration. Subjects will continue safety assessments and survival follow-up after treatment completion. Safety Reporting Period: Starts from the first TACE treatment and ends 90 days after the last dose of Iparomlimab and Tuvonralimab Injection \[non-serious adverse events (AEs) unrelated to study drugs are collected only until 30 days after the last dose\], or 30 days after the last dose of Bevacizumab Injection, or 30 days after the last TACE procedure, whichever is later. Survival Follow-up: After the safety visit period, survival status and subsequent anti-tumor therapies will be collected every 12 weeks (±7 days) via clinical or telephone follow-up until subject death, loss to follow-up, sponsor study termination, or other study completion criteria are met (whichever occurs first).

Conditions

• Hepatocellular Carcinoma (HCC)
• Immunotherapy
• PD-1
• CTLA-4
• TACE

Interventions

Type	Name	Description
PROCEDURE	TACE treatment	TACE treatment (cTACE): On-demand TACE therapy will be administered, with a maximum of 4 TACE sessions permitted.
DRUG	Iparomlimab and Tuvonralimab Injection (QL1706)	Iparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W.
DRUG	Bevacizumab	Bevacizumab Injection: 15 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W.

Timeline

• Start date: 2025-08-20
• Primary completion: 2028-01-30
• Completion: 2029-12-30
• First posted: 2025-08-17
• Last updated: 2025-08-17