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| ID | Type | Description | Link |
|---|---|---|---|
| TYS-CN-1.1PUMPâ…¡PartA |
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The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | the Tyroserleutide for injection at the dosage of 3mg/d |
| |
| Group 2 | the Tyroserleutide for injection at the dosage of 6mg/d |
| |
| Group 3 | the Tyroserleutide for injection at the dosage of 12mg/d |
| |
| Group 4 | the placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitomycin, Fluorouracil | Drug | All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| DFS(disease free survival) | six month |
| Measure | Description | Time Frame |
|---|---|---|
| 1.OS (Overall Survival) 2.QOL (quality of life) | six month |
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Inclusion Criteria:
Exclusion Criteria:
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HCC complicating branch cork after resection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen X P, professor | Contact | 027-83662599 | chenxp_53@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen X P, Professor | Tongji Medical College of Huazhong University of ScienceTechnology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A Research Institute of Tumor | Recruiting | Guangzhou | Guangdong | 510060 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2018 | |
| Reset | Nov 16, 2018 | |
| Release | Nov 20, 2018 | |
| Reset | Mar 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2018 | Nov 16, 2018 | |||
| Nov 20, 2018 |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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collection of blood sample before the operation and ahead of the third and the sixth period.
collection of the tumor tissue during the operation
|
| Mar 8, 2019 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |