small cell lung cancer
Conditions
Interventions
Trial group:Sintilimab +cisplatin/carboplatin+etoposide
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old and = 10mm by CT scan, a lymph node must be >= 15 mm in short axis when assessed by CT scan, and the thickness of the scan layer is not greater than 5mm. The measurable lesions have not received local therapy such as radiotherapy or cryotherapy; 6. ECOG score 0-2; 7. The expected survival time is not less than 3 months; 8. Adequate hematology function with absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 80 x 10^9/L, hemoglobin >= 90g/L(no history of blood transfusion within 7 days, no use of G-CSF and others Hematopoietic stimulating factor); 9. Adequate hepatic function with total bilirubin = 50ml / min (Cockcroft-Gault formula); 11. Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; 12. For female subjects of childbearing age, a urine or serum pregnancy test should be negative within 3 days before receiving the first study drug; if the urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required; 13. If there is a risk of conception, male and female patients need to use highly effective contraception (a method with a failure rate of less than 1% per year) and continue for at least 180 days after stopping the trial treatment; 14. Patients must join the study voluntarily and sign written informed consents before any trial-related procedures. They should be cooperated with treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical trials or received treatment with other research drugs or devices within 4 weeks before the first administration; 2. Previously received the following therapies: anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs that stimulates or synergistically inhibits T cell receptors (CTLA4, OX-40, CD137); 3. Received Chinese medicine with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration or received major surgery within 3 weeks before the first administration; 4. Active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that require clinical intervention; 5. Have received an organ or blood system transplantation; 6. Grade III-IV congestive heart failure (NYHA classification), poorly controlled and clinically significant arrhythmia; 7. Allergic to the active ingredients or any excipients of the drugs used in this study; 8. Patients have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; 9. Patients receive systemic steroid therapy or any other form of immunosuppressive therapy. Intermittent use of bronchodilators, inhaled corticosteroids or local injections of corticosteroids due to COPD and asthma are allowed; 10. Patients have not fully recovered from toxicity and/or complications caused by any intervention before treatment; 11. Patients were diagnosed with other malignant tumors within 5 years before the first administration. Radically cured skin basal cell carcinoma, skin squamous cell carcinoma and/or radically resected carcinoma in situ are permitted; For other malignant tumors or lung cancer, pathological or cytological diagnosis of recurrent and metastatic lesions is required; 12. Non-infectious pneumonia requiring corticosteroid treatment within 1 year before the first administration or current non-infectious pneumonia; 13. Active infection that needs to be treated, or having used systemic anti-infective drugs within one week before the first administration; 14. Mental illness or substance abuse that may affect patients' compliance; 15. Known history of Human immunodeficiency virus (HIV) infection, syphilis infection or active tuberculosis; 16. Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are also eligible: HBV viral load must be <1000 copies / ml (200 IU / ml) or below lower limit of detection. Subjects should receive anti-HBV therapy to avoid virus reactivation throughout the study chemotherapy treatment period. For anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) subjects, prophylactic anti-HBV treatment is not required, but virus reactivation needs to be closely monitored; 17. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 18. Patients received a live vaccine within 30 days before the first administration. Seasonal flu vaccines that do not contain live virus are permitted; 19. Medical history, disease, treatment or abnormal laboratory results that may interfere w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Overall Survival;Objective Response Rate;Adverse event rate; | — |
Countries
China
Contacts
Public ContactChunxia Su
Shanghai Pulmonary Hospital
Outcome results
None listed