RecruitingPhase 2NCT07337460

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

Sponsor

Northern Jiangsu People's Hospital

Enrollment

30 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma (HCC)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a natural herb-based medicine called icaritin with a chemotherapy regimen (mFOLFOX) can help prevent liver cancer from coming back after surgery. It is designed for people who had their liver cancer completely removed but are at higher risk of the cancer returning. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with liver cancer (hepatocellular carcinoma) and had it fully removed by surgery within the last 8 weeks with clear margins - You have at least one high-risk factor for recurrence (e.g., tumor larger than 5 cm, blood vessel invasion, 3 or more tumors, or a narrow surgical margin) - Your cancer has not spread beyond the liver - You are generally in good health with adequate blood counts, liver, and kidney function - If you have hepatitis B or C, you are already on antiviral treatment **You may NOT be eligible if...** - Your cancer has spread outside the liver or came back after surgery - You received any cancer treatment before surgery (chemo, immunotherapy, radiation, etc.) - You have serious liver disease (Child-Pugh B or C) or history of liver-related brain problems - You had a serious blood clot or heart attack in the last 6 months - You are pregnant 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

DRUGIcaritin 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.