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Safety and Efficacy of γδ T Cell Against 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585908
Recruitment Status : Not yet recruiting
First Posted : October 26, 2015
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Doing Biomedical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 26, 2015
Last Update Posted Date November 13, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2017)		 Reduced size of the tumor. [ Time Frame: up to one year ]
Tumor load will be evaluated by RECIST criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)		 Reduced size of the tumor. [ Time Frame: up to one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2017)		 Safety, as measured by the rate of adverse events and serious adverse events [ Time Frame: up to two years ]
Safety, as measured by the rate of adverse events and serious adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2015)		 Safety, as measured by the rate of adverse events and serious adverse events [ Time Frame: up to two years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of γδ T Cell Against Gastric Cancer
Official Title  ICMJE γδ T Cell Immunotherapy for Treatment of Gastric Cancer
Brief Summary In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Biological: CIK
    CIK cells will be used against tumor cells.
  • Biological: γδ T
    γδ T cells will be used against tumor cells.
  • Biological: CIK and γδ T
    CIK and γδ T cells will be used against tumor cells.
Study Arms  ICMJE
  • No Intervention: Experimental Group A(control group)
    regular treatment and follow up
  • Experimental: Experimental Group B
    CIK will be used against tumor cells.
    Intervention: Biological: CIK
  • Experimental: Experimental Group C
    γδ T will be used against tumor cells.
    Intervention: Biological: γδ T
  • Experimental: Experimental Group D
    CIK and γδ T will be used against tumor cells.
    Intervention: Biological: CIK and γδ T
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2015)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age:30-75
  2. Karnofsky performance status >50
  3. Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  5. Patients who have a life expectancy of at least 12 weeks
  6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

  1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
  2. Known human immunodeficiency virus (HIV) infection.
  3. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
  4. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
  5. Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: xie yanyun, master 086-15601041145 yanyun_xie@doingtimes.com
Contact: li gangyi, master 086-13901106501 gangyi_li@doingtimes.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02585908
Other Study ID Numbers  ICMJE Doing-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Doing Biomedical Co., Ltd.
Study Sponsor  ICMJE Beijing Doing Biomedical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: li gangyi, master Beijing Doing Biomedical Co., Ltd.
PRS Account Beijing Doing Biomedical Co., Ltd.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP