NCT02425748

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.

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 lung-cancer

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_1 lung-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

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

September 12, 2019

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

April 21, 2015

Last Update Submit

September 10, 2019

Conditions

Lung Cancer

Keywords

γδ T Cell, non small lung cancer, Without EGFR Mutation

Outcome Measures

Primary Outcomes (1)

  • Reduced size of the tumor.

    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: γδ T/DC-CIK cells

Interventions

DC-CIKBIOLOGICAL

DC-CIK cells will be used against tumor cells.

Group A
γδ T CellBIOLOGICAL

γδ T cells will be used against non small lung tumor.

Group B
γδ T/DC-CIK cellsBIOLOGICAL

γδ T/DC-CIK cells will be used against lung 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 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

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

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract 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 21, 2015

First Posted

April 24, 2015

Study Start

June 8, 2017

Primary Completion

December 20, 2017

Study Completion

June 20, 2019

Last Updated

September 12, 2019

Record last verified: 2018-06

Locations

CN(1)