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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02704299
Recruitment Status : Unknown
Verified March 2016 by Cellular Biomedicine Group Ltd..
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

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

Condition or disease Intervention/treatment Phase
Gastric Cancer. Biological: Autologous T cells-Based Immunotherapy Early Phase 1

Detailed Description:
Safety:AE/SAE Efficacy:immunologic function;FPS
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Study Start Date : March 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous T cells-Based Immunotherapy
Surgery Chemotherapy Autologous T cells-Based Immunotherapy
 Biological: 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.
Other Name: TCM


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free-Survival(PFS) [ Time Frame: 24months ]
    The primary objective is to assess progression free survival (PFS).


Secondary Outcome Measures :
  1. Incidences of adverse events or serious adverse events [ Time Frame: 24months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704299


Contacts
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Contact: Jiafu / Ji, Doctor

Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
Beijing Cancer Hospital
Investigators
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Principal Investigator: / / /, /
More Information
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Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT02704299    
Other Study ID Numbers: CBMG-TCM-GC-1.1
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases