- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418481
Safety and Efficiency of γδ T Cell Against Breast Cancer(Her-, er-, and pr-)
July 17, 2016 updated by: Fuda Cancer Hospital, Guangzhou
γδ T Cell Immunotherapy for Treatment of Breast Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Biological treatment center in Fuda cancer hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
DC-CIK cells will be used against tumor cells.
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DC-CIK cells will be used against tumor cells.
|
Experimental: Group B
γδ T cells will be used against tumor cells.
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γδ T cells will be used against breast tumor.
|
Experimental: Group C
Combination of γδ T cells/ DC-CIK be used against tumor cells.
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γδ T/DC-CIK cells will be used against breast tumor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduced size of the tumors
Time Frame: Up to one year
|
Up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
April 13, 2015
First Submitted That Met QC Criteria
April 15, 2015
First Posted (Estimate)
April 16, 2015
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
July 17, 2016
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gd T cell
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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