Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study (CIK)
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ClinicalTrials.gov Identifier: NCT01498055
Verified December 2011 by Gong Liang, Third Military Medical University. Recruitment status was: Recruiting
Disease Control Rates (DCR) [ Time Frame: From 12-2011 to 12-2013 ]
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
Secondary Outcome Measures
Overall Survival(OS) [ Time Frame: 2 years ]
Disease progression-free surial (Progression-Free Srvival, PFS) with observations
Biospecimen Retention: Samples With DNA
The one-time folic acid sodium anticoagulation vacuum picks bag, through the venous blood sampling 60 ml. When blood alcohol on parts of the need blood disinfects processing. After the department shows will seal in a sterile bag, 16-21 degrees Celsius save, and transported to a cell biological treatment as soon as possible a follow-up operation center GMP laboratory.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Primary lung cancer diagnosis (including small cell lung cancer, lung adenocarcinoma, lung squamous cell carcinoma and large cell carcinoma) patients
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.
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;
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.