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Safety and Efficiency of γδ T Cell Against Liver Cancer

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ClinicalTrials.gov Identifier: NCT03183219
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Jinan University Guangzhou
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
In this study, effects of γδT cells on human Liver Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

Condition or disease Intervention/treatment Phase
Liver Cancer Procedure: Cryosurgery or IRE surgery Biological: γδ T cell Other: γδ T cells/ A Cryosurgery or IRE Phase 1 Phase 2

Detailed Description:
A 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: γδ T Cell Immunotherapy for Treatment of Liver Cancer
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Group A
In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor.
Procedure: Cryosurgery or IRE surgery
Cryosurgery or IRE surgery will be used in local tumor

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).
Biological: γδ T cell
γδ T cells will be used against Liver Cancer

Experimental: Group C
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery
Other: γδ T cells/ A Cryosurgery or IRE
Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer




Primary Outcome Measures :
  1. Relief degree of tumors [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)

  2. Progress free survival(PFS) [ Time Frame: 1 year ]
  3. Overall survival(OS) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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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 Liver 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 T cells
  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

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): NCT03183219


Locations
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China, Guangdong
Biotherapy center in Fuda cancer hospital
Guangzhou, Guangdong, China, 510665
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Jinan University Guangzhou
Investigators
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Principal Investigator: Jibing Chen, PhD Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03183219     History of Changes
Other Study ID Numbers: Gd T cell and liver Ca
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Immunotherapy, γδ T Cell, Liver Cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Immunologic Factors
Hematinics
Physiological Effects of Drugs