Safety and Efficacy of γδ T Cell Against Gastric Cancer

Study Overview
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Brief Summary
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In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.

Detailed Description
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PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.

Official Title
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γδ T Cell Immunotherapy for Treatment of Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Biological: CIK
* Biological: γδ T
* Biological: CIK and γδ T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:30-75 Karnofsky performance status >50 Diagnosis with gastric cancer based on histology or the current accepted radiological measures. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Patients who have a life expectancy of at least 12 weeks Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. Known human immunodeficiency virus (HIV) infection. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. Pregnancy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- |
| No Intervention: Experimental Group A(control group)<br>regular treatment and follow up | |
| Experimental: Experimental Group B<br>CIK will be used against tumor cells. | Biological: CIK<br>* CIK cells will be used against tumor cells.<br>|
| Experimental: Experimental Group C<br>γδ T will be used against tumor cells. | Biological: γδ T<br>* γδ T cells will be used against tumor cells.<br>|
| Experimental: Experimental Group D<br>CIK and γδ T will be used against tumor cells. | Biological: CIK and γδ T<br>* CIK and γδ T cells will be used against tumor cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced size of the tumor. | Tumor load will be evaluated by RECIST criteria. | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, as measured by the rate of adverse events and serious adverse events | Safety, as measured by the rate of adverse events and serious adverse events | up to two years |