Breast Cancer
Conditions
Keywords
Immunotherapy, γδ T Cell, Breast Cancer
Brief summary
In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.
Detailed description
Breast 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, 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.
Interventions
PROCEDURECryosurgery , IRE surgery ,surgery
surgery will be used in local tumor
BIOLOGICALγδ T cells
γδ T cells will be used against
OTHERγδ T cells/ Surgery
Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer
Sponsors
Jinan University Guangzhou
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age: 18-75 Karnofsky performance status \>50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 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 Insulin dependent diabetes Thyroid disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief degree of tumors | 3 months |
| Progress free survival（PFS） | 1 year |
| Overall survival（OS） | 3 years |
Countries
China
Outcome results
None listed