Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Recurrence Free Survival Rate [Time frame: 12 months]

Secondary outcome measures (2)

• Disease Free Survival [Time frame: 24 months]
• Overall survival (OS) [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06900478 · 2024-349-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗