A Phase 2 interventional study of Group A:cytokine-induced killer cell +gefitinib and Group B:Gefitinib in Non-Small Cell Lung Cancer, sponsored by Kunming Medical University. Terminated at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-30.
Sponsored by Kunming Medical University · Phase 2, Interventional, and Treatment
Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.
Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. The epidermal growth factor receptor (EGFR) adenosine triphosphate-competitive tyrosine kinase inhibitors gefitinib showed success in the treatment of advanced adenocarcinoma NSCLC following the failure of front-line chemotherapy. However, the efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC is also low. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Biological treatment is an effective adjuvant treatment in comprehensive cancer treatment. Immunotherapy with cytokine-induced killer cells (CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum, this effect may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Kunming Medical University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Gefitinib combination with CIK cell immunotherapy
Drug: Group A:cytokine-induced killer cell +gefitinib
Gefitinib alone
Drug: Group B:Gefitinib
CIK cells: intravenous infusions; D14-16; one cycle every month,at least 6 cycles;Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity.
Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity
Progression-free survival
Time frame: up to 2 years
Overall survival
Time frame: up to 3 years
Quality-of-life
Time frame: Three years
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Kunming Medical University