Safety and Efficiency of γδ T Cell Against Breast Cancer

NCT03183206 | Completed Phase 1 DMC

• 1 other identifier: Gd T cell and Breast Ca
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

Conditions

Breast Cancer

Keywords

Immunotherapy, γδ T Cell, Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Relief degree of tumors

  3 months

• Progress free survival（PFS）

  1 year

• Overall survival（OS）

  3 years

Study Arms (3)

Group A

EXPERIMENTAL

In this group, the patients will receive under CT Cryosurgery , IRE surgery or open surgery to control the local tumor

Procedure: Cryosurgery , IRE surgery ,surgery

Group B

EXPERIMENTAL

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell)

Biological: γδ T cells

Group C

EXPERIMENTAL

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery, IRE surgery or open surgery

Other: γδ T cells/ Surgery

Interventions

Cryosurgery , IRE surgery ,surgery PROCEDURE

surgery will be used in local tumor

Group A

γδ T cells BIOLOGICAL

γδ T cells will be used against

Group B

γδ T cells/ Surgery OTHER

Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer

Group C

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 Karnofsky performance status \>50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 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 Insulin dependent diabetes Thyroid disease

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Jinan University Guangzhou: collaborator

Study Sites (1)

Biotherapy center in Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques

Study Officials

• Jibing Chen, PhD

  Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: June 15, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

CN (1)