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

Kunming Medical University

Status and phase

Terminated

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Group A:cytokine-induced killer cell +gefitinib

Drug: Group B:Gefitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01871480

CIK plus gefitinib

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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