Back to resultsD-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)
Primary Purpose
Lung Cancer, Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
D-CIK
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring D-CIK, lung cancer
Eligibility Criteria
Inclusion Criteria:
- The patient who have singed the informed consent;
- Histologically confirmed with NSCLC at stage Ⅲb～Ⅳ;
- Expected survival time is more than 2 month;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.
Exclusion Criteria:
- Hemoglobin<8.0 g/dL,White blood cell <3 x 10^9/L;Platelet count <75 x 10^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times;
- Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- Pregnant or lactating patients;
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
- Patients who are suffering from serious autoimmune disease;
- Patients who had used long time or are using immunosuppressant;
- Patients who had active infection;
- Patients who are suffering from serious organ dysfunction;
- Patients who are suffering from other cancer;
- Other situations that the researchers considered unsuitable for this study.
Sites / Locations
- Affiliated Tumor Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
D-CIK
Chemotherapy
Arm Description
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
Outcomes
Primary Outcome Measures
Progress-free survival
Secondary Outcome Measures
Overall survival
Quality of life (QOL)
The assessment will be performed using The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30).
Phenotypic analysis of T cells
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Full Information
NCT ID
NCT02651441
First Posted
January 5, 2016
Last Updated
May 23, 2016
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02651441
Brief Title
D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)
Official Title
Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).
Detailed Description
60 patients with stage Ⅲb～Ⅳ NSCLC will be randomly divided into group A（receive D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small Cell Lung Cancer
Keywords
D-CIK, lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D-CIK
Arm Type
Experimental
Arm Description
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
cisplatinum
Intervention Description
Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
Intervention Type
Biological
Intervention Name(s)
D-CIK
Intervention Description
8×10^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.
Primary Outcome Measure Information:
Title
Progress-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
Quality of life (QOL)
Description
The assessment will be performed using The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30).
Time Frame
3 years
Title
Phenotypic analysis of T cells
Description
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Time Frame
1 year
Title
Severity of adverse events
Description
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient who have singed the informed consent;
Histologically confirmed with NSCLC at stage Ⅲb～Ⅳ;
Expected survival time is more than 2 month;
Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.
Exclusion Criteria:
Hemoglobin<8.0 g/dL,White blood cell <3 x 10^9/L;Platelet count <75 x 10^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times;
Known or suspected allergy to the investigational agent or any agent given in association with this trial;
Pregnant or lactating patients;
Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
Patients who are suffering from serious autoimmune disease;
Patients who had used long time or are using immunosuppressant;
Patients who had active infection;
Patients who are suffering from serious organ dysfunction;
Patients who are suffering from other cancer;
Other situations that the researchers considered unsuitable for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guang P Wang, Physician
Phone
+86 13810661960
Email
WangGP@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi Z Zhang, Professor
Organizational Affiliation
Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Tumor Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Z Wang, Professor
Phone
020-66673666
Email
WangZY@QQ.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)
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