The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.

Detailed Description
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400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Official Title
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The Randomized, Controlled, Multicenter Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Biological: Cytokine-Induced Killer Cells
* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who can accept curative operations 18-70 years old Histologically confirmed with gastric cancer at stage Ⅳ Patients who can accept oral drugs; Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1. Exclusion Criteria: Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times Known or suspected allergy to the investigational agent or any agent given in association with this trial Pregnant or lactating patients Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection Patients who are suffering from serious autoimmune disease Patients who had used long time or are using immunosuppressant Patients who had active infection Patients who are suffering from serious organ dysfunction Patients who are suffering from other cancer Other situations that the researchers considered unsuitable for this study.

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

Sexes Eligible for Study
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Female

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Apatinib alone<br>Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib. | Drug: Apatinib<br>* Advanced gastric cancer patients take Apatinib 850mg qd by mouth.<br>* Other names: YN968D1;|
| Experimental: Apatinib+CIK<br>Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous. | Biological: Cytokine-Induced Killer Cells<br>* Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.<br>* Other names: CIK;Drug: Apatinib<br>* Advanced gastric cancer patients take Apatinib 850mg qd by mouth.<br>* Other names: YN968D1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, Apatinib, CIK