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Safety and Efficiency of γδ T Cell Against Pancreatic 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: NCT03180437
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Jinan University Guangzhou
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Tracking Information
First Submitted Date  ICMJE May 19, 2017
First Posted Date  ICMJE June 8, 2017
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE June 15, 2017
Actual Primary Completion Date June 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
  • Relief degree of tumors [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
  • Progress free survival(PFS) [ Time Frame: 1 year ]
  • Overall survival(OS) [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03180437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficiency of γδ T Cell Against Pancreatic Cancer
Official Title  ICMJE γδ T Cell Immunotherapy for Treatment of Pancreatic Cancer
Brief Summary In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example cryosurgery going to be investigated.
Detailed Description

Pancreatic tumor will be removed using tumor reducing surgery such as cryosurgery.

PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

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 Pancreatic Cancer
Intervention  ICMJE
  • Procedure: Cryosurgery or IRE surgery
    Cryosurgery or IRE surgery will be used in local tumor
  • Biological: γδ T cell
    γδ T cells will be used against Pancreatic Cancer
  • Other: γδ T cells/ A Cryosurgery or IRE
    Combination γδ T cell and Cryosurgery or IRE surgery will be used in Pancreatic Cancer
Study Arms  ICMJE
  • Experimental: Group A
    In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor.
    Intervention: Procedure: Cryosurgery or IRE surgery
  • Experimental: Group B
    In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
    Intervention: Biological: γδ T cell
  • Experimental: Group C
    In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery
    Intervention: Other: γδ T cells/ A Cryosurgery or IRE
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2019
Actual Primary Completion Date June 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 18-75
  2. Karnofsky performance status >50
  3. Diagnosis with Pancreatic Cancer based on histology or the current accepted radiological measures
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  5. Will receive cryosurgery, IRE, gd Tcells
  6. Life expectancy: Greater than 3 months
  7. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

  1. Patients with other kinds of cancer
  2. History of coagulation disorders or anemia
  3. Patients with heart disease and diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03180437
Other Study ID Numbers  ICMJE Gd T cell and Pancreatic Ca
Has Data Monitoring Committee Yes
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 Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Jinan University Guangzhou
Investigators  ICMJE
Principal Investigator: Jibing Chen, PhD Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date June 2018

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