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

NCT01498055 | Unknown

• 1 other identifier: GLiang
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Keywords

lung cancer; CIK cells; therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Overall Survival(OS)

  2 years

Study Arms (2)

CIK therapy group

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Liang Gong

Chongqing, Chong Qing, 400038, China

RECRUITING

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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiangdong Zhou

  Southwest Hospital Third Military University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: December 23, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 22, 2012

Record last verified: 2011-12

Locations

CN (1)