Status:
TERMINATED
CIK Cell Transfusion Plus Gefitinib As Second Or Third-Line Treatment for Advanced Adenocarcinoma Non-Small Cell Lung Cancer
Lead Sponsor:
Kunming Medical University
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01871480
Start Date
May 1 2013
End Date
May 1 2016
Last Update
December 30 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University
Kunming, Yunnan, China, 650118