A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Combination Product: Apatinib,Paclitaxel,Cisplatin,RT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18 to 70 years old (man or female); Pathologically diagnosed with esophageal squamous cell carcinoma; Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography; Patients with measurable lesions(According to the criteria in RECIST1.1); Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Life expectancy greater than or equal to 3 months; Major organ function has to meet the following certeria: (1) For results of blood routine test HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; (2) For results of blood biochemical 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: Have received prior treatment with chemotherapy or radiotherapy； Have high blood pressure and antihypertensive drug treatment can not control; Patients with severe cardiovascular disease ; Accompanied by esophageal perforation and esophagotracheal fistula; Patients with active bleeding or bleeding tendency; Pregnant or lactating women; The researchers think inappropriate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib+Paclitaxel+Cisplatin+RT<br>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 | Combination Product: Apatinib,Paclitaxel,Cisplatin,RT<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pathological complete response rate(pCR) | The lesion disappeared completely by pathology | within 3 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |