Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates.
This prospective, single-arm phase II study evaluates a combination regimen of PD-1 inhibitor (sintilimab) plus CTLA-4 inhibitor (ipilimumab N01), bevacizumab biosimilar, and HAIC for patients with initially unresectable intermediate-advanced HCC. The primary goal is to achieve a higher surgical conversion rate with manageable safety
Written informed consent must be signed prior to initiation of any study-related procedures;
Age ≥ 18 years, and ≤75 years, regardless of gender;
Clinically diagnosed or histologically/cytologically confirmed hepatocellular carcinoma (HCC) according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition);
No prior anti-tumor therapy for HCC before study treatment
Fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma.
Recurrent HCC.
Clinically diagnosed hepatic encephalopathy within the most recent 6 months.
Autoimmune hepatitis (requiring liver biopsy confirmation);
Single group
Bevacizumab Biosimilar IBI305
Drug7.5 mg/kg, iv, q3w, 3 cycles (discontinue 1 week before surgery)
ipilimumab N01
Drug3mg/kg, iv, q6w, 2 cycles
Sintilimab
Drug200mg, iv, q3w, 4 cycles
HAIC
DrugFOLFOX-HAIC, q3w, 4 cycles
Conversion resection rate
The percentage of initially unresectable patients who underwent curative resection after protocol-specified conversion therapy.
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
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.
Overall survival
OS was defined as the time from the first dose of study drug to death due to anycause.
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