Clinical trial NCT01498055: Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: lung cancer
CIK cells
therapy
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary lung cancer diagnosis (including small cell lung cancer, lung adenocarcinoma, lung squamous cell carcinoma and large cell carcinoma) patients

Brief summary: To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.

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 criteria: 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.

Primary outcomes:
measure: Disease Control Rates (DCR)
timeFrame: From 12-2011 to 12-2013
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Chong Qing
country: China
facility: Liang Gong
state: Chong Qing
Study officials:
affiliation: Southwest Hospital Third Military University
name: Xiangdong Zhou
role: STUDY_CHAIR
References: