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

This study is currently recruiting participants.

Verified December 2011 by Third Military Medical University

Sponsor:

Information provided by (Responsible Party):

Gong Liang, Third Military Medical University

ClinicalTrials.gov Identifier:

NCT01498055

First received: November 24, 2011

Last updated: March 21, 2012

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2011

Last Updated Date

March 21, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01498055 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Survival(OS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Disease progression-free surial (Progression-Free Srvival, PFS) with observations

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

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.

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

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

CIK therapy group
control group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01498055

Other Study ID Numbers ^ICMJE

GLiang

Has Data Monitoring Committee

Responsible Party

Gong Liang, Third Military Medical University

Study Sponsor ^ICMJE

Third Military Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Xiangdong Zhou

Southwest Hospital Third Military University

Information Provided By

Third Military Medical University

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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