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Safety and Efficiency of γδ T Cell Against Hepatocellular Liver 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: NCT02425735
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
Jinan University Guangzhou
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Tracking Information
First Submitted Date  ICMJE April 21, 2015
First Posted Date  ICMJE April 24, 2015
Last Update Posted Date July 19, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
Reduced size of the tumors [ Time Frame: Up to one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 Hepatocellular Liver Cancer
Official Title  ICMJE γδ T Cell Immunotherapy for Treatment of Hepatocellular Liver Cancer
Brief Summary In this study, effects of γδT cells on human hepatocellular liver cancer in combination with tumor reducing surgery, for example cryosurgery going to be investigated.
Detailed Description Liver 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: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Liver Cancer
Intervention  ICMJE
  • Biological: DC-CIK cells
    DC-CIK cells will be used against tumor cells.
  • Biological: γδ T cells
    γδ T cells will be used against breast tumor.
  • Biological: γδ T/DC-CIK cells
    γδ T/DC-CIK cells will be used against breast tumor.
Study Arms  ICMJE
  • Experimental: Group A
    DC-CIK cells will be used against tumor cells.
    Intervention: Biological: DC-CIK cells
  • Experimental: Group B
    γδ T cells will be used against tumor cells.
    Intervention: Biological: γδ T cells
  • Experimental: Group C
    Combination of γδ T cells/ DC-CIK be used against tumor cells.
    Intervention: Biological: γδ T/DC-CIK cells
Publications * Alnaggar M, Xu Y, Li J, He J, Chen J, Li M, Wu Q, Lin L, Liang Y, Wang X, Li J, Hu Y, Chen Y, Xu K, Wu Y, Yin Z. Allogenic Vγ9Vδ2 T cell as new potential immunotherapy drug for solid tumor: a case study for cholangiocarcinoma. J Immunother Cancer. 2019 Feb 8;7(1):36. doi: 10.1186/s40425-019-0501-8.

*   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: April 23, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (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 hepatocellular carcinoma 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, gd Tcells/ DC-CIK.
  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 NCT02425735
Other Study ID Numbers  ICMJE Gd T cell and Hepatocellular
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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 Not Provided
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date April 2015

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