CIK Cell Transfusion Plus Gefitinib As Second Or Third-Line Treatment for Advanced Adenocarcinoma Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kunming Medical University
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Age between 18 to 80 years

• Histologically or cytologically proven advanced adenocarcinoma non-small-cell lung cancer

• Life expectancy more than 12 weeks

• Not received EGFR agent or cell immunotherapy before entry into this study

• World Health Organization- Eastern Cooperative Oncology Group Performance Status 0-3

• Gefitinib as the second or third line therapy

• More than 4 weeks must have completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects

• Disease measurable

• Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.0×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 75×109/L, Hemoglobin more than 80g/L, Serum total bilirubin less than 1.25 folds of the upper normal limit (ULN), Serum glutamic-oxal (o) acetic transaminase: less than 2.5×ULN, Serum glutamate pyruvate transaminase: less than 2.5×ULN, Serum creatinine: less than 1.25×ULN, Blood urea nitrogen: less than 2×ULN.

• Pregnancy test: the test of women of child-bearing period must be negative before entry into this study

• Subject must have good compliance and voluntarily to sign a written informed consent

Exclusion Criteria:

• Acute infection

• Uncontrolled concurrent illness: hypersensitiveness, asthma, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, serious heart valve disease

• Psychiatric illness, pharmacological dependence, or other situation that would limit compliance with study requirements

• History of other neoplasms

• Coagulation disorder and bleeding tendency

• Pertinacious hypertension（systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) after aggressive therapy

• Brain metastasis with symptomatic

• Severe liver dysfunction

• Autoimmune disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, thyroadenitis, et al )

• Patients who diagnosed as virus hepatitis, syphilis or HIV, or other infectious diseases

• Employment of corticosteroids or other immunodepressive hormone therapies

• With main organs transplantation

• Pregnant or lactating women

• Known or suspected in patients with severe hypersensitivity to CIK or gefitinib or to any other component of gefitinib

• Patients receiving any other investigational agents in 30 days or prepare to participate in other investigation in the clinical period