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

Lung Cancer Clinical Trial

— CIK  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01498055
• Other study ID #: GLiang
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 24, 2011
• Last updated: March 21, 2012
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2011
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Description:

A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
China	Liang Gong	Chong Qing	Chong Qing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rates (DCR)	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	From 12-2011 to 12-2013	Yes
Secondary	Overall Survival(OS)	Disease progression-free surial (Progression-Free Srvival, PFS) with observations	2 years	Yes