NCT07337460

Efficacy and Safety of Icaritin Combined With mFOLFOX in Postoperative HCC With High-risk Recurrence Factors

Icaritin Soft Capsules Combined With Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in HCC With High-risk Recurrence Factors: A Single-center, Phase II, Single-arm, Prospective Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Northern Jiangsu People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Patients enrolled in this study received a first HAIC treatment (mFOLFOX-HAIC) 4-8 weeks after radical surgery. 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. The protocol specified: 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. Follow-up was conducted every 8-12 weeks until 12 months postoperatively or the termination of the study. The follow-up included the patient's survival status, tumor recurrence, adverse drug reactions,living quality, routine blood tests, liver function, and electrocardiogram.Contrast-enhanced abdominal CT (layer thickness ≤5 mm) or contrast-enhanced MRI (including DWI sequence) were used for tumor recurrence.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil	Postoperative 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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-11-30
• Completion: 2028-01-31
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: China