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)

Sponsor
Anhui Provincial Hospital
Study ID
NCT07128251
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 17, 2025
Start date
Aug 20, 2025
Status verified
Aug 2025
Primary completion
Jan 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental group
    TACE → Iparomlimab and Tuvonralimab Injection (QL1706) + Bevacizumab Injection (Q3W, 2 cycles). On-demand TACE therapy will be administered concurrently, with a maximum of 4 TACE sessions permitted.

Primary Outcome Measure

Progression-Free Survival (PFS) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [ Time Frame: 2-year ]

Central Contacts

Related Studies