Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study
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Purpose
To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.
| Study Type: | Observational |
| Study Design: | 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 |
- Disease Control Rates (DCR) [ Time Frame: From 12-2011 to 12-2013 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| CIK therapy group |
| control group |
Detailed Description:
A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Primary lung cancer diagnosis (including small cell lung cancer, lung adenocarcinoma, lung squamous cell carcinoma and large cell carcinoma) patients
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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Gong Liang, MD, Third Military Medical University |
| ClinicalTrials.gov Identifier: | NCT01498055 History of Changes |
| Other Study ID Numbers: | GLiang |
| Study First Received: | November 24, 2011 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Institutional Review Board China: Ministry of Health |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 21, 2013