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.
Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance;
Age ≥ 18 years, regardless of gender;
HCC confirmed histologically/cytologically or meeting the clinical diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition), with no evidence of extrahepatic metastasis;
No prior systemic therapy for HCC (including investigational systemic agents);
Pregnant or lactating women;
Histologically/cytologically confirmed HCC containing fibrolamellar, sarcomatoid, or cholangiocarcinoma components;
History of other primary malignancies within 5 years (except adequately treated and stable non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix);
Current or prior central nervous system (CNS) metastases or leptomeningeal metastasis;
Single group
lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab
DrugIparomlimab 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.
Conversion resection rate
The percentage of initially unresectable patients who underwent curative resection after protocol-specified conversion therapy.
R0 Resection Rate
Proportion of patients achieving complete tumor resection with microscopically negative margins after successful conversion therapy
Pathological Complete Response
The proportion of patients in whom no residual viable tumor cells are detected upon histopathological examination of the surgically resected specimen.
Major Pathological Response
the proportion of patients with significantly reduced residual viable tumor cells in the surgically resected specimens (typically defined as ≤50% residual viable tumor cells, according to the Chinese Expert Consensus on Conversion and Perioperative Therapy for Primary Liver Cancer (2024 Edition)).
Objective response rate
the percentage of participants in the analysis population who had a CR(Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) usingRECIST1.1 based oninvestiqator assessment
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