non small cell lung cancer
Conditions
Interventions
Two groups:Autologous DIK cells vs control
Sponsors
Jiangsu Decon Bio-Sci-Technology Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 18 to 70 years, KPS score more than at least 60 points, estimated survival of more than 6 months; 2. The diagnosis of patients with non-small cell lung cancer(including adenocarcinoma, squamous cell carcinoma and large cell undifferentiated carcinoma); 3. TNM staging IIIb-IV stage; 4. Adequate organ function, meeting the following criteria: absolute neutrophil count (ANC) more than 1.5*10^9/L, Platelet count more than at least 80*10^9/L, Hemoglobin more than at least 100g/L; ALT and AST less than at least 2.5 times the upper limit of normal, CCr more than at least 60ml/min or Cr less than at least 1.5 times the upper limit of normal; 5. Female: Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment and must not be lactating; 6. Male: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment; 7. No serious mental illness and no serious heart, liver, kidney, lung function is not complete, not combined with other deadly diseases; 8. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. TNM staging I-IIIa stage; 2. Unable to compliance study plan or research program or can't stick to 2 years follow-up; 3. Serious or uncontrolled systemic disease or any instability of systemic disease (including but not limited to active infection, grade 3 hypertension, unstable angina pectoris, Congestive heart failure, grade III or IV cardiac disease, serious cardiac arrhythmias, liver and kidney function disorders or metabolic diseases), history of neurological or mental disorders, etc.; 4. Patients received organ transplantation; 5. Patients with history of autoimmune disease, for example SLE, rheumatic arthritis and angiitis; 6. No other malignancies diagnosed within the last 5 years; 7. Patients received other clinical trials in 3 months; 8. Patients in pregnancy or breast-feeding period; 9. Unwilling to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;quality of life;cytokine levels;lymphocyte subsets;tumor markers;PFS; | — |
Countries
China
Contacts
Public ContactShi Hongzhen
Outcome results
None listed