Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study

• Conditions: Lung Cancer

• Registration Number: NCT01498055
• Lead Sponsor: Third Military Medical University

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

Study Timeline

• Study First Submitted: 2011-11-24
• Status Verified: 2011-12
• Study Start: 2011-12
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Control Rates (DCR)	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

Name	Time	Method
Overall Survival(OS)	2 years	Disease progression-free surial (Progression-Free Srvival, PFS) with observations

Trial Locations

Locations (1)

Liang Gong; 🇨🇳 Chong Qing, Chong Qing, China