Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer

Study Overview
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Brief Summary
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The investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.

Official Title
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Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer

Conditions
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Two Different Treatment Methods

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients,age≥18years Confirmed by Pathology or histology of Gastric cancer Patients who failed first-line chemotherapy The ECOG physical status score:0 to 2 Expected survival ≥3months Patients should be voluntary to the trail and provide with signed informed consent. The researchers believe patients can benefit from the study. Exclusion Criteria: Pregnant or lactating women Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories Patients with apatinib contraindications Patients of doctors considered unsuitable for the trail

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib 5 days' continuous use and 2 days' off<br>Apatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer | Drug: Apatinib<br>* Apatinib 500mg with Docetaxel 60mg/m2<br>|
| Active Comparator: Apatinib 500mg continuous use<br>Apatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer | Drug: Apatinib<br>* Apatinib 500mg with Docetaxel 60mg/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress free survival(PFS) | From data of randomization until the date of first dccumentde progression or date of death from any cause | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate (DCR) | investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor | 1year | 
| Objective tumor response rate(ORR) | difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments | 1year | 
| overall survival (os) | difined as the length of time from random assignment to death or to last contact | 1year | 
| Quality of life score | a questionnaire developed to assess the quality of life of cancer patients | 1 year | 
| adverse events | adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events | 1 year |