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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Biological: Combination; Biological: DC-CIK; Biological: γδ T Cell

• Registration Number: NCT02418481
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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.

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

Study Timeline

• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group C	Combination	Combination of γδ T cells/ DC-CIK be used against tumor cells.
Group A	DC-CIK	DC-CIK cells will be used against tumor cells.
Group B	γδ T Cell	γδ T cells will be used against tumor cells.

Primary Outcome Measures

Name	Time	Method
Reduced size of the tumors	Up to one year

Trial Locations

Locations (1)

Biological treatment center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China