NCT07337421

Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma With High-risk Recurrence Factors

Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX(Modified Folinic Acid, Fluorouracil, and Oxaliplatin) in Hepatocellular Carcinoma 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 postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with mFOLFOX in hepatocellular carcinoma 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. 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,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	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.A second HAIC session was administered 3 weeks later, depending on individual patient conditions, with a maximum of two treatments.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: China