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The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib+Paclitaxel+Cisplatin+RT | Experimental | Apatinib:250mg,po,qd, d1-35; Paclitaxel:50mg/m2 iv, d1,8,15,22,29; Cisplatin: 30mg/m2 iv, d1,8,15,22,29; Radiotherapy:41.4Gy/23f , 1.8Gy/f,5 f/w |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib,Paclitaxel,Cisplatin,RT | Combination Product | Apatinib Mesylate Tablets 250mg qd p.o. d1-35; Paclitaxel:50mg/m2 iv d1,8,15,22,29; Cisplatin: 30mg/m2 iv d1,8,15,22,29; RT:41.4Gy/23f , 1.8Gy/f,5 f/w |
| Measure | Description | Time Frame |
|---|---|---|
| The pathological complete response rate(pCR) | The lesion disappeared completely by pathology | within 3 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| R0-resection rate | There was no residual by the microscope | within 3 weeks after surgery |
| Disease-free survival(DFS) | Baseline to measured date of recurrence or death from any cause |
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Inclusion Criteria:
(1) For results of blood routine test
a) ALT and AST≤2.5×ULN; b) TBIL<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion Criteria:
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| 3 years |
| Overall survival (OS) | Baseline to measured date of death from any cause | 1year |
| Adverse events Toxicity | Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit. | 3 years |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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