This is a single-center, single-arm, prospective trial to explore the efficacy and safety of Icaritin Soft Capsules combined with postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with Modified Folinic acid, Fluorouracil, and Oxaliplatin (mFOLFOX) in hepatocellular carcinoma (HCC) 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.
Single group
Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil
DrugPostoperative adjuvant transarterial chemoinfusion with mFOLFOX.mFOLFOX-HAIC: Oxaliplatin 85 mg/m²via arterial infusion for 2-3 hours, leucovorin calcium 400 mg/m² for 1-2 hours, followed by a 400 mg/m²arterial infusion of 5-fluorouracil for 5 minutes , and continuous arterial infusion at 2400 mg/m²for 46 hours.Within two weeks after the first HAIC procedure, patients should begin taking 2400mg of Icaritin Soft Capsules twice daily for three months, with the total treatment duration not exceeding one year.A second HAIC session was administered 3 weeks later, depending on individual patient conditions, with a maximum of two treatments.
Recurrence-free survival (RFS)
Recurrence-free survival
Overall survival (OS)
Overall survival
Time to recurrence (TTR)
Time to recurrence
Safety:treatment-related adverse events (AE) rates
Safety:treatment-related adverse events (AE) rates
living quality
Patient quality of life was evaluated with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire- Hepatocellular Carcinoma 18(EORTC QLQ-HCC18 )scale.Standardized scores (range: 0-100) were calculated, where increased scores correspond to worse outcomes (i.e., more severe symptoms or impaired quality of life)
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