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Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC-CIK
γδ T Cell
γδ T/DC-CIK cells
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring γδ T Cell, non small lung cancer, Without EGFR Mutation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age:18-75
  2. Karnofsky performance status >50
  3. Diagnosis with non small lung tumors based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, gd Tcells/ DC-CIK.
  5. Life expectancy: Greater than 3 months
  6. 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

Sites / Locations

  • Biological treatment center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

DC-CIK cells will be used against tumor cells.

γδ T cells will be used against tumor cells.

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

Outcomes

Primary Outcome Measures

Reduced size of the tumor.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2015
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02425748
Brief Title
Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)
Official Title
γδ T Cell Immunotherapy for Treatment of
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.
Detailed Description
Non small lung cancer 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
γδ T Cell, non small lung cancer, Without EGFR Mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
DC-CIK cells will be used against tumor cells.
Arm Title
Group B
Arm Type
Experimental
Arm Description
γδ T cells will be used against tumor cells.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Combination of γδ T cells/ DC-CIK be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
DC-CIK
Intervention Description
DC-CIK cells will be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
γδ T Cell
Intervention Description
γδ T cells will be used against non small lung tumor.
Intervention Type
Biological
Intervention Name(s)
γδ T/DC-CIK cells
Intervention Description
γδ T/DC-CIK cells will be used against lung tumor.
Primary Outcome Measure Information:
Title
Reduced size of the tumor.
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18-75 Karnofsky performance status >50 Diagnosis with non small lung 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
Facility Information:
Facility Name
Biological treatment center in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)

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