Overview

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