Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC

Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for Hepatocellular Carcinoma With High-Risk Recurrence Factors:A Single-Center, Prospective Study

This is a prospective, single-center, phase II study，to evaluate the efficacy and safety of icariin soft capsules combined with TACE as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocarcinoma
• Intervention / Treatment: Drug: Icariin Soft Capsules+TACE

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hua Li; Phone Number: +86-13060975202; Email: lihua100@yeah.net

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Contact: Hua Li; Phone Number: +86-13060975202; Email: lihua100@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 80 years;
• ECOG Performance Status (PS) of 0 or 1;
• Histologically or cytologically diagnosed as HCC
• Fully recovered from surgical resection or ablation prior to enrollment;
• Presence of the following high-risk recurrence factors after resection or ablation: tumor maximum diameter > 5 cm; multiple tumors; microvascular or major vascular invasion; margin distance from the tumor edge < 1 cm; poorly differentiated tumors (Edmondson grade III-IV); lymph node metastasis; persistent abnormal AFP or abnormal prothrombin (DCP);
• Child-Pugh class A5-B7;
• Expected survival time > 3 months;
• Normal major organ function: Hemoglobin ≥ 80 g/L, Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L, Platelet count ≥ 50 × 10^9/L, Serum albumin ≥ 30 g/L, Total bilirubin ≤ 2 ULN, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤ 2.5 × ULN, Alkaline Phosphatase (ALP) ≤ 2.5 × ULN, Creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 ml/min, International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;
• Negative HIV test results at screening;
• Hepatitis B virus (HBV) DNA<500 IU/mL;
• No major vascular invasion (Vp3 or Vp4) of the portal vein or any level of major vascular invasion of the hepatic veins or inferior vena cava;
• Within 7 days prior to screening, women of childbearing potential must confirm a negative serum pregnancy test and agree to use effective contraception during the study drug administration and for 60 days after the last dose of the study drug;

Exclusion Criteria:

• Known cases of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
• HCC recurrence prior to study enrollment;
• Co-infection with HBV and delta hepatitis virus;
• Clinically significant ascites (Note: ascites detectable only through imaging studies are permitted to participate in the study);
• History of hepatic encephalopathy;

• Receipt of any other investigational drug treatment within 4 weeks prior to Day

  1 of Cycle 1;

• Presence of abdominal wall fistula, gastrointestinal perforation, refractory non-healing gastric ulcers, or history of active gastrointestinal bleeding within 6 months prior to enrollment;
• History of another malignancy tumor , except for the cured skin basal cell carcinoma and cervical carcinoma in situ)
• Active tuberculosis;
• Functional impairment of major organs (heart, lungs, kidneys, etc.), severe infections, or > grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) version 5.0);
• Very early-stage HCC, solitary tumors, size < 2 centimeters;
• Any allergy to the drugs used in the TACE regimen or known components of epimedium soft capsules;
• History of organ transplantation;
• Pregnant or breastfeeding female patients, or those unwilling to use contraception during the trial;
• Any other diseases, metabolic disorders, abnormal physical examination results, or laboratory test results that raise suspicion of contraindications for the investigational drug, may affect the reliability of study results, or place the patient at high risk for treatment complications, or affect patient compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icariin Soft Capsules + TACE; TACE treatment was performed one month after surgery, and Icariin Soft Capsules for disease progression or study termination.	Drug: Icariin Soft Capsules+TACE; TACE: perform preoperative infusion chemotherapy, then selectively inject 2 to 5 mL of iodized oil and embolize. Icariin Soft Capsules：take 6 tablets each time, orally, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Free Survival Rate	The proportion of patients who did not experience recurrence or death	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	DFS defined as the time from date of treatment until the date of recurrence or death due to any cause	24 months
Overall survival (OS)	OS defined as the time from date of treatment until the date of death due to any cause	24 months

Collaborators and Investigators

• Sponsor: Hua Li

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 2024-349-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No