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This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group 1 | Active Comparator | Docetaxel plus Nedaplatin combined with Endostar |
|
| Test Group 2 | Active Comparator | Docetaxel plus Nedaplatin |
|
| Control Group | No Intervention | No medicine intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 year disease-free survival rate | the percentage of the patients whose disease cannot be detected after curative therapy in three years | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From the time of randomization to the time of death for any reason. | 3 years |
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Inclusion Criteria:
Blood Routine:
HB≥90 g/L(No blood transfusion within 14 days), ANC≥1.5×109/L, PLT ≥80×109/L. Biochemical examination: ALB≥30g / L(No blood transfusion within 14 days), ALT<2ULN; AST<2ULN TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C053989 | nedaplatin |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Nedaplatin | Drug | 80 mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles |
|
| Endostar | Drug | 7.5mg/m2,once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |