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Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer

NCT01481259 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-07-03

No results posted yet for this study

Summary

Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.

Conditions

Interventions

BIOLOGICAL

Autologous cytokine-induced killer cell

Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.

OTHER

Pemetrexed

Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • People's Hospital of Guangxi Zhuang Autonomous Region

    lead OTHER

Principal Investigators

  • Guosheng Feng, M.D · People's Hospital of Guangxi Zhuang Autonomous Region

  • Hui Lin, M.D · People's Hospital of Guangxi Zhuang Autonomous Region

  • Yuan Liang, M.D · Guangxi Department of Public Health

  • Heming Lu, M.D · People's Hospital of Guangxi Zhuang Autonomous Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481259 on ClinicalTrials.gov