RecruitingPhase 2NCT07337421

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


Sponsor

Northern Jiangsu People's Hospital

Enrollment

30 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether delivering chemotherapy directly into the liver's blood supply (hepatic arterial infusion using mFOLFOX) after surgery can reduce the risk of liver cancer (hepatocellular carcinoma, or HCC) coming back in patients who have features that make recurrence more likely. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed liver cancer (hepatocellular carcinoma) and have had successful surgery to completely remove it (with clean margins) - You have not received any prior cancer treatments (chemotherapy, targeted therapy, immunotherapy, radiation) before surgery - Your cancer has at least one high-risk recurrence feature (e.g., tumor larger than 5 cm, blood vessel invasion, satellite nodules, or multiple tumors) - Your liver function, blood counts, and ECOG performance status meet study requirements **You may NOT be eligible if...** - Your cancer involves certain rare subtypes (fibrotic or mixed HCC) - Surgery was incomplete (cancer remains) - You have had prior treatment for HCC - You have severe liver disease or poor organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFOX :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.


Locations(1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, China

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NCT07337421


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