Clinical Efficacy and Safety of Dendritic Cytotoxic Lymphocyte(DC-CTL) Cell Infusion in NSCLC Patients

Study Overview
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Brief Summary
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Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.

Detailed Description
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60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL 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 DC-CTL Immune Cell for Non-Small Cell Lung Cancer

Conditions
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NSCLC

Intervention / Treatment
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* Drug: gemcitabine
* Biological: DC-CTL
* Drug: cisplatinum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient who have signed the informed consent; Histologically confirmed with NSCLC at stage III-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; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(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: DC-CTL<br>After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment | Drug: gemcitabine<br>* gemcitabine 1000mg/m2 IV on day 1 an day 8, repeat every 3 weeks<br>* Other names: Gemzar;Biological: DC-CTL<br>* 8×10^9 DC-CTL cells for each infusion, IV(In the vein) for 3 cycles, each cycle received four infusions on day 14,16,30 and 32<br>Drug: cisplatinum<br>* cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.<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 day 1 an day 8, repeat every 3 weeks<br>* Other names: Gemzar;Drug: cisplatinum<br>* cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.<br>|

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DC-CTL, NSCLC