Safety and Efficiency of γδ T Cell Against Liver Cancer
NCT ID: NCT03183219
Last Updated: 2020-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2017-06-15
2019-06-15
Brief Summary
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Detailed Description
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NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks.
Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor.
Cryosurgery or IRE surgery
Cryosurgery or IRE surgery will be used in local tumor
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).
γδ T cell
γδ T cells will be used against Liver Cancer
Group C
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery
γδ T cells/ A Cryosurgery or IRE
Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer
Interventions
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Cryosurgery or IRE surgery
Cryosurgery or IRE surgery will be used in local tumor
γδ T cell
γδ T cells will be used against Liver Cancer
γδ T cells/ A Cryosurgery or IRE
Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer
Eligibility Criteria
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Inclusion Criteria
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
2. History of coagulation disorders or anemia
3. Patients with heart disease
18 Years
75 Years
ALL
No
Sponsors
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Jinan University Guangzhou
OTHER
Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Jibing Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
Locations
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Biotherapy center in Fuda cancer hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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Gd T cell and liver Ca
Identifier Type: -
Identifier Source: org_study_id
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