D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer

Conditions
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Lung Cancer, Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Cisplatin
* Biological: D-CIK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-CIK<br>After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment. | Drug: Gemcitabine<br>* Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.<br>* Other names: Gemzar;Drug: Cisplatin<br>* Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.<br>* Other names: cisplatinum;Biological: D-CIK<br>* 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.<br>|
| Active Comparator: Chemotherapy<br>After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up. | Drug: Gemcitabine<br>* Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.<br>* Other names: Gemzar;Drug: Cisplatin<br>* Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.<br>* Other names: cisplatinum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 
| Quality of life (QOL) | The assessment will be performed using The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30). | 3 years | 
| Phenotypic analysis of T cells | The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell | 1 year | 
| Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D-CIK, lung cancer