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Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Cancer Biological: DC-CIK cells Biological: γδ T cells Biological: γδ T/DC-CIK cells Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: γδ T Cell Immunotherapy for Treatment of Hepatocellular Liver Cancer
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
DC-CIK cells will be used against tumor cells.
 Biological: DC-CIK cells
DC-CIK cells will be used against tumor cells.
Experimental: Group B
γδ T cells will be used against tumor cells.
 Biological: γδ T cells
γδ T cells will be used against breast tumor.
Experimental: Group C
Combination of γδ T cells/ DC-CIK be used against tumor cells.
 Biological: γδ T/DC-CIK cells
γδ T/DC-CIK cells will be used against breast tumor.


Outcome Measures
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Primary Outcome Measures :
  1. Reduced size of the tumors [ Time Frame: Up to one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT02425735


Locations
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China, Guangdong
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Jinan University Guangzhou
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02425735    
Other Study ID Numbers: Gd T cell and Hepatocellular
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: April 2015
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Immunotherapy, γδ T Cell, heptocellular liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases