Hepatocellular Carcinoma
Conditions
Interventions
Adjuvant Therapy group:Icariin Soft Capsules Combined with TACE as Adjuvant Therapy
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old; 2. ECOG PS is 0 or 1; 3. Clinically diagnosed with hepatocellular carcinoma, anatomical radical resection of hepatocellular carcinoma, and postoperative pathological confirmation of hepatocellular carcinoma 4. Complete recovery from surgical resection or ablation prior to enrollment; 5. There are the following high-risk factors for recurrence after resection or ablation: tumor length and diameter >5cm; multiple tumors; microvascular or macrovascular invasion; The resection margin is =80 g/L; b) absolute neutrophil count (ANC) >=1.5×10^9/L; c) Platelet count>=50×10^9/L; d) serum albumin>=30 g/L; e) total bilirubin =50ml/min; Coagulation function: i) International normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN; j) activated partial thromboplastin time; 9. Negative HIV test result at screening; 10. Have documented hepatitis virology status, based on HBV and HCV tests at screening: For patients with active HBV: HBV DNA < 500 IU/mL during screening, initiation of anti-HBV therapy at least 14 days prior to randomization, and willingness to continue anti-HBV therapy during the study; 11. No major macrovascular (coarse) invasion of the portal vein (Vp3 or Vp4) or no macrovascular invasion of any grade in the hepatic vein or inferior vena cava; 12. Within 7 days prior to screening, females of childbearing potential must have a confirmed negative serum pregnancy test and agree to use effective contraception during the use of the study drug and within 60 days after the last dose of the study drug; 13. Patients must be able to understand and willing to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; 2. HCC recurrence before study enrollment; 3. Co-infection with HBV and hepatitis D virus infection; 4. Clinically significant ascites (Note: only ascites that can be found by imaging examination are allowed to participate in the study); 5. History of hepatic encephalopathy; 6. Treatment with any other trial drug within 4 weeks prior to Day 1 of Cycle 1; 7. Have abdominal wall fistula or gastrointestinal perforation, refractory unhealed gastric ulcer, or history of active gastrointestinal bleeding within 6 months prior to enrollment; 8. History of malignancies other than HCC within 5 years prior to screening, except for malignancies with very low risk of metastasis or death (such as 5-year OS rate > 90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 9. Active tuberculosis; 10. Functional impairment, serious infection, or > grade 2 adverse events of vital organs (heart, lungs, kidneys, etc.) (Common Terminology Criteria for Adverse Events (CT CAE) version 5.0); 11. Very early HCC, solitary tumor, size < 2 cm; 12. Hypersensitivity to TACE regimen drugs and any of the known icariin softgel ingredients; 13. History of organ transplantation; 14. Pregnant or lactating female patients, or those who are unwilling to use contraception during the test; 15. Any other disease, metabolic disorder, abnormal results of physical examination or laboratory tests, and there is reason to suspect that there is a disease or condition that may cause the use of the trial drug to be contraindicated, or affect the reliability of the study results, or put the patient at high risk of treatment complications, or affect the patient's compliance; 16. Other conditions that the investigator considers unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival (RFS);Overall Survival (OS);Security; | — |
Countries
China
Contacts
Public ContactHua Li
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed