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

Early Phase 1

• Conditions: Gastric Cancer.
• Interventions: Biological: Autologous T cells-Based Immunotherapy

• Registration Number: NCT02704299
• Lead Sponsor: Shanghai AbelZeta Ltd.

Brief Summary

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

Detailed Description

Safety:AE/SAE Efficacy:immunologic function;FPS

Study Timeline

• Study First Submitted: 2016-02-26
• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-04
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-11
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous T cells-Based Immunotherapy	Autologous T cells-Based Immunotherapy	Surgery Chemotherapy Autologous T cells-Based Immunotherapy

Primary Outcome Measures

Name	Time	Method
Progression-Free-Survival(PFS)	24months	The primary objective is to assess progression free survival (PFS).

Secondary Outcome Measures

Name	Time	Method
Incidences of adverse events or serious adverse events	24months