The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.

Study Overview
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Brief Summary
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Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.

Detailed Description
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Safety:AE/SAE Efficacy:immunologic function;FPS

Official Title
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A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.

Conditions
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Gastric Cancer.

Intervention / Treatment
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* Biological: Autologous T cells-Based Immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 to 80 years, males and females. Subjects who understand and sign the consent form for this study. The pathologically confirmed advanced gastric cancer T3、T4 or T2 and Metastasis in lymph nodes. Subjects are surgical candidates. No distant metastasis (M0) and No distant lymph node metastasis. Expected survival time of at least 6 months. Exclusion Criteria: Subjects who do not sign the consent form for this study. The subject has an allergic history of medicine or food. The subject has uncontrolled or hard-to-control diseases of cardiovascular,liver,kidney or lung,endocrine system. The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases. The subject has an history of other malignant tumour. The subject has history of alcoholism, drug abuse, or mental illness in the 12 years prior to this trial. The subject has participated in any other clinical trial in the 3 months prior to this trial. The subject is pregnant, lactating or planning to conceive within the next 24 months. The subject has any other unsuitable or adverse condition to be determined by the investigator.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous T cells-Based Immunotherapy<br>Surgery Chemotherapy Autologous T cells-Based Immunotherapy | Biological: Autologous T cells-Based Immunotherapy<br>* TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.<br>* Other names: TCM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free-Survival(PFS) | The primary objective is to assess progression free survival (PFS). | 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of adverse events or serious adverse events |  | 24months |