Small Cell Lung Cancer
Conditions
Interventions
PD-1 antibody:Sintilimab
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: >= 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; 5. ECOG PS: 0-2; 6. Expected survival time >= 3 months; 7. Hematological function is sufficient, defined as 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); 8. Adequate liver function, defined as total bilirubin levels = 50ml / min (Cockcroft-Gault formula); 10. 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. 11. 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; 12. 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; Note: If abstinence is the subject's usual lifestyle and preferred methods of contraception, abstinence is acceptable; 13. Participants voluntarily joined the study and signed written informed consent prior to the implementation of any study procedures, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical trial or receiving other study drugs or research device treatment within 4 weeks before the first administration; 2. Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs that target another type of stimulus or synergistic inhibition of T cell receptors (eg, CTLA4, OX-40, CD137); 3. Have received Chinese traditional medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration; 4. There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention; 5. Have active central nervous system (CNS) metastases and / or cancerous meningitis; 6. Have received a solid organ or blood system transplant; 7. Grade III-IV congestive heart failure (New York Heart Association), poorly controlled and clinically significant arrhythmias; 8. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, occurred within 6 months before enrollment. History of deep venous thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months before enrollment); 9. Have an allergic reaction to the active ingredients of Sintilimab and/or any excipients; 10. Active autoimmune disease requiring systemic treatment (such as the use of condition-improving drugs, corticosteroids, or immunosuppressants) occurred 2 years before the first dose. Alternative therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic treatment; 11. Patients requiring long-term use of systemic corticosteroid. Patients with COPD and asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids were eligible; 12. Have not fully recovered from the toxicity and/or complications caused by any intervention before starting treatment (ie, <= grade 1 or reached baseline, excluding fatigue or alopecia); 13. Other malignancies diagnosed within 5 years before the first administration, excluding basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ after radical resection. For other malignant tumors or lung cancer, pathological or cytological diagnosis of recurrent and metastatic lesions is required; 14. History of non-infectious pneumonia requiring corticosteroid treatment or current non-infectious pneumonia within 1 year before the first dose; 15. Active infection requiring treatment or systemic anti-infective drugs used within one week before the first administration; 16. Known conditions of mental illness or substance abuse that may affect compliance with the test requirements; 17. History of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive), syphilis infection (syphilis antibody positive), active tuberculosis; 18. 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 less Lower limit of detection. Subjects should receive anti-HBV therapy to avoid virus reactivation throughout the study chemotherapy treatment perio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Overall Survival;Duration of response;Objective Response Rate;Disease Control Rate;Quality of Life;Quality of Life; | — |
Countries
China
Contacts
Public ContactChunxia Su
Shanghai Pulmonary Hospital
Outcome results
None listed