This study aims to explore the value of the 'HAIC Apatinib Camrelizumab' triple regimen for perioperative treatment of resectable hepatocellular carcinoma. The study adopts a multicenter, randomized, open-label, controlled design and plans to enroll 208 patients, randomly assigned 1:1 to the experimental group and the control group. The experimental group will receive preoperative HAIC combined with targeted-immunotherapy triple regimen neoadjuvant therapy, followed by radical resection, and continue postoperative adjuvant therapy; the control group will undergo surgery directly. The primary endpoint is EFS, and secondary endpoints include R0 resection rate, pCR, MPR, OS, and 1-year/2-year/3-year EFS rates.
1: 1. Age 18-80, both male and female are acceptable;
1: 1. Merge distant metastases;
Parallel
Camrelizumab (anti-PD-1 inhibitor)
Drug200 mg administered as intravenous infusion over approximately 30 minutes, every 3 weeks. Given for 2-4 cycles preoperatively and continued postoperatively for at least 6 cycles.
Apatinib Mesylate Tablets
Drug250 mg taken orally once daily, every 3 weeks. Given for 2-4 cycles preoperatively and continued postoperatively for at least 6 cycles.
FOLFOX-HAIC
DrugOne cycle of hepatic arterial infusion (HAIC) using the FOLFOX regimen: Oxaliplatin 85 mg/m² over 0-2 hours, Leucovorin 400 mg/m² over 2-3 hours, 5-FU 400 mg/m² bolus at 3 hours, followed by 5-FU 2400 mg/m² continuous infusion for 44 hours. Administered once during the neoadjuvant phase.
Surgery Alone
Other interventionPatients undergo upfront radical hepatectomy without any perioperative systemic therapy. Postoperative follow-up is conducted according to routine clinical practice.
EFS
R0 resection rate
MPR rate
OS
1-year EFS rate
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