Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC

Hua Li

Status and phase

Not yet enrolling

Phase 2

Conditions

Hepatocarcinoma

Treatments

Drug: Icariin Soft Capsules+TACE

Study type

Interventional

Funder types

Other

Identifiers

NCT06900478

2024-349-02

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.