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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01498055

Acronym

CIK

Enrollment

120

Registered

2011-12-23

Start date

2011-12-31

Completion date

2013-12-31

Last updated

2012-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, CIK cells, therapy

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Disease Control Rates (DCR)	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

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

Countries

China

Outcome results