Back to resultsSafety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC-CIK cells
γδ T cells
γδ T/DC-CIK cells
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Immunotherapy, γδ T Cell, heptocellular liver cancer
Eligibility Criteria
Inclusion Criteria:
- Age:18-75
- Karnofsky performance status >50
- Diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures.
- Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- Will receive cryosurgery, gd Tcells/ DC-CIK.
- Life expectancy: Greater than 3 months
- Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with other kinds of cancer
- History of coagulation disorders or anemia
- Patients with heart disease and diabetes
Sites / Locations
- Biological treatment center in Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
DC-CIK cells will be used against tumor cells.
γδ T cells will be used against tumor cells.
Combination of γδ T cells/ DC-CIK be used against tumor cells.
Outcomes
Primary Outcome Measures
Reduced size of the tumors
Secondary Outcome Measures
Full Information
NCT ID
NCT02425735
First Posted
April 21, 2015
Last Updated
July 17, 2016
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT02425735
Brief Title
Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer
Official Title
γδ T Cell Immunotherapy for Treatment of Hepatocellular Liver Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Immunotherapy, γδ T Cell, heptocellular liver cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
DC-CIK cells will be used against tumor cells.
Arm Title
Group B
Arm Type
Experimental
Arm Description
γδ T cells will be used against tumor cells.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Combination of γδ T cells/ DC-CIK be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
DC-CIK cells
Intervention Description
DC-CIK cells will be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
γδ T cells
Intervention Description
γδ T cells will be used against breast tumor.
Intervention Type
Biological
Intervention Name(s)
γδ T/DC-CIK cells
Intervention Description
γδ T/DC-CIK cells will be used against breast tumor.
Primary Outcome Measure Information:
Title
Reduced size of the tumors
Time Frame
Up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age:18-75
Karnofsky performance status >50
Diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures.
Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
Will receive cryosurgery, gd Tcells/ DC-CIK.
Life expectancy: Greater than 3 months
Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
Patients with other kinds of cancer
History of coagulation disorders or anemia
Patients with heart disease and diabetes
Facility Information:
Facility Name
Biological treatment center in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30736852
Citation
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 Vgamma9Vdelta2 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.
Results Reference
derived
Learn more about this trial
Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer
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