Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study (CIK)
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ClinicalTrials.gov Identifier: NCT01498055 |
Recruitment Status
: Unknown
Verified December 2011 by Gong Liang, Third Military Medical University.
Recruitment status was: Recruiting
First Posted
: December 23, 2011
Last Update Posted
: March 22, 2012
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Condition or disease |
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Lung Cancer |
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer |
Study Start Date : | December 2011 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Group/Cohort |
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CIK therapy group |
control group |
- 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
- Overall Survival(OS) [ Time Frame: 2 years ]Disease progression-free surial (Progression-Free Srvival, PFS) with observations
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498055
China, Chong Qing | |
Liang Gong | Recruiting |
Chong Qing, Chong Qing, China, 400038 | |
Contact: Liang Gong 13983965893 gonglw1@gmail.com | |
Sub-Investigator: Liang Gong |
Study Chair: | Xiangdong Zhou | Southwest Hospital Third Military University |
Responsible Party: | Gong Liang, MD, Third Military Medical University |
ClinicalTrials.gov Identifier: | NCT01498055 History of Changes |
Other Study ID Numbers: |
GLiang |
First Posted: | December 23, 2011 Key Record Dates |
Last Update Posted: | March 22, 2012 |
Last Verified: | December 2011 |
Keywords provided by Gong Liang, Third Military Medical University:
lung cancer CIK cells therapy |
Additional relevant MeSH terms:
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |