Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma With High-risk Recurrence Factors
NCT07337421 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-01-13
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.
Conditions
- Hepatocellular Carcinoma (HCC)
Interventions
- 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.
Sponsors & Collaborators
-
Northern Jiangsu People's Hospital
lead OTHER
Principal Investigators
-
Dou-sheng Bai · Clinical Medical College, Yangzhou University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2027-09-01
- Completion
- 2027-12-01
Countries
- China
Study Locations
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