Hepatocarcinoma
Conditions
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.
Interventions
DRUGIcariin 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.
Sponsors
Hua Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival Rate | 12 months | The proportion of patients who did not experience recurrence or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | 24 months | DFS defined as the time from date of treatment until the date of recurrence or death due to any cause |
| Overall survival (OS) | 24 months | OS defined as the time from date of treatment until the date of death due to any cause |
Countries
China
Contacts
Primary ContactHua Li
Outcome results
None listed