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

March 21, 2012 updated by: Gong Liang, Third Military Medical University

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

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

Study Overview

Status

Unknown

Conditions

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

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chong Qing
      • Chong Qing, Chong Qing, China, 400038
        • Recruiting
        • Liang Gong
        • Contact:
        • Sub-Investigator:
          • Liang Gong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
control group
CIK therapy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 12-2011 to 12-2013

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival(OS)
Time Frame: 2 years
Disease progression-free surial (Progression-Free Srvival, PFS) with observations
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Study Chair: Xiangdong Zhou, Southwest Hospital Third Military University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLiang

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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