Safety and Efficiency of γδ T Cell Against Breast Cancer(Her-, er-, and pr-)

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Biological: DC-CIK; Biological: γδ T Cell; Biological: Combination

Study type: Interventional

Funder types: Other

Identifiers

NCT02418481

Gd T cell

Details and patient eligibility

About

In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Full 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 and DC-CIK, they will be infused to the patients as immunotherapy.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age:18-75
2. Karnofsky performance status >50
3. Diagnosis with breast tumors based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery, gd Tcells/ DC-CIK.
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

1. Patients with other kinds of cancer
2. History of coagulation disorders or anemia
3. Patients with heart disease and diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Group A

Experimental group

Description:

DC-CIK cells will be used against tumor cells.

Treatment:

Biological: DC-CIK

Group B

Experimental group

Description:

γδ T cells will be used against tumor cells.

Treatment:

Biological: γδ T Cell

Group C

Experimental group

Description:

Combination of γδ T cells/ DC-CIK be used against tumor cells.

Treatment:

Biological: Combination