An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric

Study Overview
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Brief Summary
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The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric

Detailed Description
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This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by apatinib mesilate.The main research object for first-line treatment failure Ⅲ/Ⅳ integration of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary research is to evaluate the safety of apatinib for second-line treatment of esophageal and esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and explore the relationship between VEGFR-2 high expression and apatinib efficacy and related prognostic factors. Thirty patients were enrolled in the study group. The group was expected to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the CRF table for details.

Official Title
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An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric

Conditions
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Esophagus Cancer, Stage III, Esophageal Gastric Cardia Type Metaplasia, Esophagus Cancer, Stage IV

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 and ≤ 75 years of age Have failed for 1 lines of chemotherapy ECOG performance scale 0 - 2. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min. Life expectancy of more than 12 months Exclusion Criteria: Existing therapy related toxicity of prior chemotherapy and/or radiation therapy Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure Any factors that influence the usage of oral administration The center of the tumor invaded local large blood vessels Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3). Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. Less than 4 weeks from the last clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Apatinib：500 mg，po，qd | Drug: Apatinib<br>* Targeted therapy Apatinib：500 mg，po，qd<br>* Other names: YN968D1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective Response Rate(ORR):The proportion of patients who have been reduced to a certain amount and maintained a certain amount of time, including the CR + PR case. | Through study completion, an average of 0.5 year | 
| median Overall Survival | median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason. | Through study completion, an average of 1.5 year |