A Phase 1/2 interventional study of Cryosurgery or IRE surgery and γδ T cell in Lung Cancer, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-13.
Sponsored by Fuda Cancer Hospital, Guangzhou · Phase 1/2, Interventional, and Treatment
In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated
Lung 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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Fuda Cancer Hospital, Guangzhou is the lead sponsor of 113 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age: 18-75 Karnofsky performance status >50 Diagnosis with Lung 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
In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor
Procedure: Cryosurgery or IRE surgery
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
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
Cryosurgery or IRE surgery will be used in local tumor
γδ T cells will be used against Lung Cancer
Combination γδ T cell and Cryosurgery or IRE surgery will be used in Lung Cancer
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors
Time frame: 3 months
Progress free survival（PFS)
Time frame: 1 year
Overall survival（OS）
Time frame: 3 years
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Fuda Cancer Hospital, Guangzhou