An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Study Overview
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Brief Summary
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This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

Detailed Description
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In the last decade, front-line chemotherapy has been considered a standard therapeutic regimen for the extension of survival time in patients with metastatic gastric cancer (mGC). New evidence suggests that salvage chemo-therapies, as second-line treatments, may have a survival advantage when compared with best supportive care. After failure of second-line chemotherapy, the results of further treatment are poor, yielding response rates of 0% to 5% with no evidence of prolonged survival. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor, Had been approved by the CFDA for the treatment of advanced gastric cancer, However, this study defines a variety of inclusion/exclusion criteria, efficacy and safety are not well reflect in the real world for the treatment of advanced gastric cancer. Therefore, an Open Label, Prospective, Multicentre, Non-interventional Study could evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

Official Title
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An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Conditions
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Metastatic Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 》18 years old Advanced Metastatic Gastric Cancer The doctor evaluate that patients had benefit from treatment The patients signed the written informed consent Exclusion Criteria: Apatinib has been confirmed for allergy sufferers Pregnant or lactating women Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction) Doctors think doesn't inclusion

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apatinib<br>Apatinib Tablets: 850 mg,po, once daily , 28 days for a cycle | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0. | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause. | 1 years | 
| Progression-free survival | A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death. | 8 months | 
| Objective response rate | Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apatinib, metastatic gastric cancer, Non-interventionalStudy