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Completed

NCT Number: NCT02418481

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

DC-CIK

Biological

DC-CIK cells will be used against tumor cells.

γδ T cell

Biological

γδ T cells will be used against breast tumor.

Combination

Biological

γδ T/DC-CIK cells will be used against breast tumor.

Primary outcomes

  1. Reduced size of the tumors

    Time frame: Up to one year

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Jinan University Guangzhou

Registry information

Official study title

γδ T Cell Immunotherapy for Treatment of Breast Cancer

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2015
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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