Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC

NCT06900478 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2024-349-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocarcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival Rate

  The proportion of patients who did not experience recurrence or death

  12 months

Secondary Outcomes (2)

• Disease Free Survival

  24 months

• Overall survival (OS)

  24 months

Study Arms (1)

Icariin Soft Capsules + TACE

EXPERIMENTAL

TACE treatment was performed one month after surgery, and Icariin Soft Capsules for disease progression or study termination.

Drug: Icariin Soft Capsules+TACE

Interventions

Icariin Soft Capsules+TACE DRUG

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.

Icariin Soft Capsules + TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Hua Li: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hua Li

CONTACT

+86-13060975202; lihua100@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Liver Surgery and Liver Transplantation Center

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 28, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)