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

NCT07337460 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

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.

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
2025-11-01
Primary Completion
2027-11-30
Completion
2028-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07337460 on ClinicalTrials.gov