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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease
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 Design

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Study Type :	Observational
Estimated Enrollment :	120 participants
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
Study Start Date :	December 2011
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	December 2013

Groups and Cohorts

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Group/Cohort
CIK therapy group
control group

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Disease Control Rates (DCR) [ Time Frame: 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 :

1. Overall Survival(OS) [ Time Frame: 2 years ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China, Chong Qing
Liang Gong	Recruiting
Chong Qing, Chong Qing, China, 400038
Contact: Liang Gong 13983965893 gonglw1@gmail.com
Sub-Investigator: Liang Gong

Sponsors and Collaborators

Third Military Medical University

Investigators

Study Chair:	Xiangdong Zhou	Southwest Hospital Third Military University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gong Liang, MD, Third Military Medical University
ClinicalTrials.gov Identifier:	NCT01498055 History of Changes
Other Study ID Numbers:	GLiang
First Posted:	December 23, 2011
Last Update Posted:	March 22, 2012
Last Verified:	December 2011

Keywords provided by Gong Liang, 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