small-cell lung cancer
Conditions
Interventions
Test Group:DC-CIK/NK cells
Control group :0.9%NaCl + 1% Serum albumin
Sponsors
Cell Biotherapy Center, The Third Affiliated Hospital, The Third Military Medical University, Chongqing, China
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients signed a consent form for participation in the study with well compliance; 2. Age rang 18 to 85 years; 3. Patients pathologically confirmed clear small-cell lung cancer and had been cured with concurrent radiotherapy in combination with chemotherapy; 4. Limited-stage disease is defined as disease confined to ipsilateral hemithorax which can be safely encompassed within a radiation field; 5. Measurable or evaluable disease; 6. ECOG performance status 0-2; 7. Life expectancy longer than 12weeks; 8. Granulocyte count more than 3.0*10^9/L; lymphocyte count more than 3.0*10^9/L ;hemoglobin level more than 75 g/L; platelet count more than 50*10^9/L; bilirubin less than at least 1.5mg/dl, Creatinine less than at least normal limits; AST less than 2 normal limits; ALT less than 2 normal limits.
Exclusion criteria
Exclusion criteria: 1. Interstitial pneumonitis or pulmonary fibrosis; 2. Other respiratory diseases that precluded radiotherapy; 3. Positive tests for HIV; 4. Malignant pleural effusion or malignant pericardial effusion; 5. Active concomitant or a recent 3 years history of any malignancy; 6. Uncontrolled angina pectoris, myocardial infarction or congestive heart failure; 7. Uncontrolled diabetes mellitus or hypertension; 8. Severe infection; 9. Intestinal paralysis or obstruction; 10. Other serious concomitant medical conditions; 11. Patient participating or having participated in a clinical trial with another investigational drug with 30 days before the start of this clinical trial; 12. Pregnancy or lactation; 13. The organ transplantation patients with long-term use of immunosuppressive agents; 14. The severe autoimmune disease patients with use of immunosuppressive agents; 15. History of patient is allergic to biological products (such as IL-2), allergic reactions or other serious reaction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;2-year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Effective rate;Quality of life;Changes in Lymphocyte subsets;Adverse events;1-year survival rate; | — |
Countries
China
Contacts
Public ContactXiang Xu
Outcome results
None listed