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

NCT ID: NCT02704299

Last Updated: 2016-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-09-30

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

Conditions

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Gastric Cancer.

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous T cells-Based Immunotherapy

Surgery Chemotherapy Autologous T cells-Based Immunotherapy

Group Type EXPERIMENTAL

Autologous T cells-Based Immunotherapy

Intervention Type BIOLOGICAL

TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.

Interventions

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Autologous T cells-Based Immunotherapy

TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.

Intervention Type BIOLOGICAL

Other Intervention Names

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TCM

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jiafu / Ji, Doctor

Role: CONTACT

Other Identifiers

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CBMG-TCM-GC-1.1

Identifier Type: -

Identifier Source: org_study_id

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