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.
Voluntarily participate in the study and provide written informed consent.
Age 18-75 years, inclusive (male or female).
Histologically or cytologically confirmed HCC, or clinically diagnosed HCC according to the *Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition)*.
Barcelona Clinic Liver Cancer (BCLC) Stage A, B, or C, not amenable to curative treatment (e.g., surgical resection, liver transplantation, or ablation).
Known fibrolamellar HCC, sarcomatoid HCC, mixed hepatocellular cholangiocarcinoma, or cholangiocarcinoma; history of other active malignancies within 5 years or concurrently with HCC. Cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma *in situ* of the prostate, cervix, or breast) are permitted.
Presence of Vp3 or Vp4 portal vein tumor thrombosis (PVTT), any grade of hepatic vein or inferior vena cava invasion; any grade of bile duct invasion. *Note: Vp1 or Vp2 PVTT is permitted.*
Presence of extrahepatic spread (EHS).
Intrahepatic lesion(s) with maximum diameter ≥ 10 cm, > 10 intrahepatic lesions, or intrahepatic tumor burden ≥ 70% of liver volume, per RECIST v1.1.
Single group
TACE treatment
Procedure/SurgeryTACE treatment (cTACE): On-demand TACE therapy will be administered, with a maximum of 4 TACE sessions permitted.
Iparomlimab and Tuvonralimab Injection (QL1706)
DrugIparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W.
Bevacizumab
DrugBevacizumab Injection: 15 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W.
Progression-Free Survival (PFS) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Defined as the time from initiation of study intervention to the first occurrence of either investigator-assessed (RECIST v1.1) radiographic disease progression or death from any cause.
Objective Response Rate (ORR)
Proportion of subjects achieving Complete Response (CR) or Partial Response (PR) among all enrolled subjects (assessed by investigators per RECIST v1.1 and mRECIST).
Disease Control Rate (DCR)
Proportion of subjects achieving CR, PR, or Stable Disease (SD) among all enrolled subjects (assessed by investigators per RECIST v1.1 and mRECIST)
Overall Survival (OS)
Time from the start of therapy to death from any cause.
Adverse event (AE)
Adverse events (AEs), Serious Adverse events (SAEs), surgery related safety.
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Anhui Provincial Hospital
Lead sponsor
Qilu Hospital of Shandong University
Collaborator
Henan Provincial People's Hospital
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Xi'an International Medical Center Hospital
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
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