EGFR wild-type lung adenocarcinoma
Conditions
Interventions
chemotherapy group:CIK cells combined chemotherapy group
Sponsors
Cancer Hospital Affiliated to Zhengzhou University & Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as stage IV naive EGFR wild-type lung adenocarcinoma by image, tissue and/or cytology; or relapse after operation (if the patient received adjuvant chemotherapy and the interval between the last chemotherapy and relapse is at least six months. The method of EGFR mutation is ARMS; 2. EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC; 3. There should be at least one measurable lesion (by CT or MRI); 4. No other cancer history (except skin squamous cell carcinoma after surgery); 5. Age between 18 to 75 years old; 6. World health organization- Eastern Cooperative Oncology Group Performance Status 0-1; 7. Life expectancy more than 3 months and can be followed-up; 8. Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.5*10^9/L, Neutrophils: more than 1.5*10^9/L, Platelets: more than 80*10^9/L, Hemoglobin more than 90g/L, Serum total bilirubin less than 1.5 folds of the upper normal limit (ULN), Serum glutamic-oxal (o) acetic transaminase: less than 2.5*ULN (if there is liver metastasis less than 5*ULN); Serum creatinine: less than 1.0*ULN, Prothrombin time, Active partial thromboplastin time, Fibrinogen, Thrombin time are in normal ranges; 9. Women of child-bearing period must take effective contraceptive measures during all the time of study. During the period of screening and study the results of blood and urine pregnancy test should be negative; 10. Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy; 11. Willing to comply with the ban and constraints for this study protocol specified; 12. Informed consent and willing to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Accepted other study drugs 30 days before the beginning of this study; 2. Brain metastases with clinical symptoms (with exception of control after radiation); 3. Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment; 4. Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection; 5. Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements; 6. Known allergy to any kind of component of study drugs; 7. Active rheumatic diseases; 8. Organ transplant recipients; 9. Poor compliance; 10. Pregnant women; 11. Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;objective response rate;quality of life; | — |
Countries
China
Contacts
Public ContactGao Quanli
Outcome results
None listed