Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study

Study Overview
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Brief Summary
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To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.

Detailed Description
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A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer

Official Title
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A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 70 year old, KPS score >50 points, estimate survival > 3 months; Primary lung cancer patients after chemotherapy or radiation therapy; Primary lung cancer patients after targeted therapy; Primary lung cancer patients with lung function can not accept operation or unwilling to operation; Primary lung cancer recurrence or surgery can't complete resection; Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf, etc.); No serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases; Patients Voluntary attempt, and informed consent. Exclusion Criteria: History of cardiovascular disease: congestive heart failure > New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction; Cachexia; or other deadly diseases; Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit; Active infection; Pregnant or lactating women At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents); Now or recently will join another experimental clinical study ; Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, HIV infections, etc.), or influence on the results of clinical trials for analysis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CIK therapy group<br> | |
| control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rates (DCR) | Lung lesions of disease control rates DCR (CR + PR + SD), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST) standard | From 12-2011 to 12-2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | Disease progression-free surial (Progression-Free Srvival, PFS) with observations | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, CIK cells, therapy