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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icariin Soft Capsules + TACE | Experimental | TACE treatment was performed one month after surgery, and Icariin Soft Capsules for disease progression or study termination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Free Survival Rate | The proportion of patients who did not experience recurrence or death | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | DFS defined as the time from date of treatment until the date of recurrence or death due to any cause | 24 months |
| Overall survival (OS) | OS defined as the time from date of treatment until the date of death due to any cause |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Li | Contact | +86-13060975202 | lihua100@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 24 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |