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

NCT ID: NCT01498055

Last Updated: 2012-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CIK therapy group

No interventions assigned to this group

control group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Gong Liang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangdong Zhou

Role: STUDY_CHAIR

Southwest Hospital Third Military University

Locations

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Liang Gong

Chongqing, Chong Qing, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Liang Gong

Role: primary

13983965893

Other Identifiers

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GLiang

Identifier Type: -

Identifier Source: org_study_id

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