NCT02418481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

April 13, 2015

Last Update Submit

July 17, 2016

Conditions

Breast Cancer

Keywords

γδ T Cellbreast cancerher2-er-pr-

Outcome Measures

Primary Outcomes (1)

  • Reduced size of the tumors

    Up to one year

Study Arms (3)

Group A

EXPERIMENTAL

DC-CIK cells will be used against tumor cells.

Biological: DC-CIK

Group B

EXPERIMENTAL

γδ T cells will be used against tumor cells.

Biological: γδ T Cell

Group C

EXPERIMENTAL

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

Biological: Combination

Interventions

DC-CIKBIOLOGICAL

DC-CIK cells will be used against tumor cells.

Group A
γδ T CellBIOLOGICAL

γδ T cells will be used against breast tumor.

Group B
CombinationBIOLOGICAL

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

Group C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with other kinds of cancer
  • History of coagulation disorders or anemia
  • Patients with heart disease and diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 16, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 19, 2016

Record last verified: 2015-04

Locations

CN(1)