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There is no standard treatment strategy for recurrent or metastatic esophageal squamous cell carcinoma patients now, especially after the second-line treatment. Most of the patients have the bad ECOG (Eastern Cooperative Oncology Group) score and prognosis. Chemotherapy, radiotherapy, surgery are usually unacceptable for them. Previous data showed that apatinib treatment significantly improved OS(overall survival) and PFS(progression-free survival) with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib Treatment | Experimental | Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular en-dothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. Previous data showed that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | the time with no progression from the treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | the time from the treatment to death | 24 weeks |
| Overall Response Rate | partial response and complete response | 4 weeks |
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Inclusion Criteria:
1)For regular test results: HB(hemoglobin) ≥ 90g / L (14 days without blood transfusion); ANC(absolute neutrophil count) ≥ 1.5 × 109 / L; PLT(platelet) ≥ 80 × 109 / L 2)Biochemical tests results: Bilirubin <1.5 times the upper limit of normal (ULN) ALT(Alanine aminotransferase) and AST≤2.5 × ULN; liver metastases, if any, the ALT and AST≤5 × ULN; Endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula) 8. Informing consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| kuaile zhao, doctor | Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Yangpu District East Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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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 |
|---|---|
| C553458 | apatinib |
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|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |