Back to resultsTreatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CIK cells with PD-1 blocking
standard lung cancer treament
CIK cells without PD-1 blocking
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- non-small cell lung cancer;
- more than 50% tumor tissues positive with PD-L1;
- EGFR and ALK wild type
- no other tumors
Exclusion Criteria:
- with systematic diseases shortening survival
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CIK cells with PD-1 blocking
CIK cells without PD-1 blocking
Arm Description
CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment
CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive
Outcomes
Primary Outcome Measures
progression-free survival
metastasis-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT03282435
First Posted
September 12, 2017
Last Updated
September 12, 2017
Sponsor
Dalian University
1. Study Identification
Unique Protocol Identification Number
NCT03282435
Brief Title
Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody
Official Title
Treatment of Non-small Cell Lung Cancer With CIK Cells Blocked by PD-1 Antibody
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CIK cells with PD-1 blocking
Arm Type
Experimental
Arm Description
CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment
Arm Title
CIK cells without PD-1 blocking
Arm Type
Active Comparator
Arm Description
CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive
Intervention Type
Biological
Intervention Name(s)
CIK cells with PD-1 blocking
Intervention Description
CIK cellular therapy with PD-1 blocking
Intervention Type
Other
Intervention Name(s)
standard lung cancer treament
Intervention Description
standard non-small cell lung cancer treatment: surgery, chemotherapy
Intervention Type
Biological
Intervention Name(s)
CIK cells without PD-1 blocking
Intervention Description
CIK cellular therapy without PD-1 blocking
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
5 years
Title
metastasis-free survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-small cell lung cancer;
more than 50% tumor tissues positive with PD-L1;
EGFR and ALK wild type
no other tumors
Exclusion Criteria:
with systematic diseases shortening survival
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
haoren wang
Phone
86-041162893507
Email
haoren_wang@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaolin Yuan
Organizational Affiliation
The Affiliated Zhongshan Hospital of Dalian University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
age, gender, tumor staging
Learn more about this trial
Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody
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