- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183219
Safety and Efficiency of γδ T Cell Against Liver Cancer
γδ T Cell Immunotherapy for Treatment of Liver Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510665
- Biotherapy center in Fuda cancer hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-75
- Karnofsky performance status >50
- Diagnosis with Liver Cancer based on histology or the current accepted radiological measures
- Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- Will receive cryosurgery, IRE, gd T cells
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor.
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Cryosurgery or IRE surgery will be used in local tumor
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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).
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γδ T cells will be used against Liver Cancer
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Experimental: Group C
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery
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Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief degree of tumors
Time Frame: 3 months
|
It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
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3 months
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Progress free survival(PFS)
Time Frame: 1 year
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1 year
|
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Overall survival(OS)
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jibing Chen, PhD, Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gd T cell and liver Ca
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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