Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Third Military Medical University.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Gong Liang, Third Military Medical University
First received: November 24, 2011
Last updated: March 21, 2012
Last verified: December 2011
To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.
||Observational Model: Case Control
Time Perspective: Prospective
||A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer
Primary Outcome Measures:
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
CIK therapy group
A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders 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
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01498055
|Chong Qing, Chong Qing, China, 400038 |
|Contact: Liang Gong 13983965893 email@example.com |
|Sub-Investigator: Liang Gong |
Third Military Medical University
||Southwest Hospital Third Military University
No publications provided
||Gong Liang, MD, Third Military Medical University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 24, 2011
||March 21, 2012
||United States: Institutional Review Board
China: Ministry of Health
Keywords provided by Third Military Medical University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases