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This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions 21 days after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups:6mg/d Tyroserleutide (injection), or placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Tyroserleutide for injection | Active Comparator | the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets,6 tablets,po,tid |
|
| the placebo group | Placebo Comparator | the placebo Gan Fu Le Tablets,6 tablets,po,tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gan Fu Le Tablets | Drug | 6 Tablets,tid,po |
|
| Measure | Description | Time Frame |
|---|---|---|
| OS (Overall Survival) | The time from randomization to death due to any reason | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| RFS(Recurrence Free Survival) | The time from randomization to recurrence, metastasis or death due to any reason | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| C484773 | H-Tyr-Ser-Leu-OH |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Tyroserleutide for injection | Drug | 6mg/d, 5days,ivgtt |
|
| Placebo | Drug | 0mg/d, 5days,ivgtt |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |