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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)

NCT07128251 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Henan Provincial People's Hospital

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Shaanxi Provincial Cancer Hospital

    collaborator OTHER

  • Xi'an International Medical Center Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Anhui Provincial Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2028-01-30
Completion
2029-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128251 on ClinicalTrials.gov