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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.

Brief Summary:
In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.

Condition or disease Intervention/treatment Phase
Gastric Cancer Biological: CIK Biological: γδ T Biological: CIK and γδ T Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: γδ T Cell Immunotherapy for Treatment of Gastric Cancer
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
No Intervention: Experimental Group A(control group)
regular treatment and follow up
Experimental: Experimental Group B
CIK will be used against tumor cells.
Biological: CIK
CIK cells will be used against tumor cells.

Experimental: Experimental Group C
γδ T will be used against tumor cells.
Biological: γδ T
γδ T cells will be used against tumor cells.

Experimental: Experimental Group D
CIK and γδ T will be used against tumor cells.
Biological: CIK and γδ T
CIK and γδ T cells will be used against tumor cells.




Primary Outcome Measures :
  1. Reduced size of the tumor. [ Time Frame: up to one year ]
    Tumor load will be evaluated by RECIST criteria.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02585908


Contacts
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Contact: xie yanyun, master 086-15601041145 yanyun_xie@doingtimes.com
Contact: li gangyi, master 086-13901106501 gangyi_li@doingtimes.com

Locations
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China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
China, Henan
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
China, Jiangsu
Huai'An First People'S Hospital
Huaian, Jiangsu, China, 223300
China, Zhejiang
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China, 310002
Sponsors and Collaborators
Beijing Doing Biomedical Co., Ltd.
Investigators
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Study Chair: li gangyi, master Beijing Doing Biomedical Co., Ltd.
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Responsible Party: Beijing Doing Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02585908    
Other Study ID Numbers: Doing-001
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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