This is a single-center, single-arm, prospective trial to explore the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with mFOLFOX in hepatocellular carcinoma with high-risk recurrence factors.
Age ≥18 years and ≤75 years.
Histologically/cytologically confirmed hepatocellular carcinoma (HCC) (fibrotic HCC and mixed HCC/biliary carcinoma subtypes were excluded from inclusion criteria), with no prior treatment for HCC (including but not limited to chemotherapy, targeted therapy, immunotherapy, cell therapy, local radiotherapy, and interventional therapy) before surgery.
Patients who underwent radical surgery within the first 8 weeks and meet the following criteria: a. Histologically confirmed negative surgical margins (R0) for radical surgery: 1) No residual cancer on gross intraoperative or postoperative imaging; 2) Liver margins>1cm from tumor boundary, or margins ≤1cm with no tumor cell remnants in resected pathological tissue; b. Imaging examination (enhanced chest CT, abdominal CT or MRI, pelvic CT or MRI) performed ≥4 weeks after surgical resection or ablation to confirm complete radiological response.
ECOG score ranges from 0 to 1.
Presence of extrahepatic metastasis, residual lesions, or recurrence on imaging after surgery or ablation.
Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery.
Child-Pugh classification grade B or C, or a history of hepatic encephalopathy.
Presence of clinically significant pericardial effusion; or clinical symptoms requiring drainage of pleural effusion or ascites.