small cell lung cancer
Conditions
Interventions
Sintilimab combined with albumin paclitaxel and platinum-containing regimen:None
Sponsors
Beijing Friendship Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent before implementing any test-related procedures; 2.Aged >= 18 ahd 3 months; 9.Sufficiency of organ function, subjects need to meet the following laboratory indicators: The absolute value of neutrophils (ANC) >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin>9g/dL, total bilirubin = 60 mL/min, good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN; thyroid function is normal, and myocardial enzyme spectrum is within the normal range. 10.The signed informed consent form with name and time indicates that the patient has been informed of all relevant matters before joining the group; 11.Good compliance, the patient and family members agree to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1.Mixed SCLC and NSCLC confirmed by histology or cytology; 2.Receive systemic systemic treatment of Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration; 3.Active autoimmune diseases that require systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 4.Receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent drugs) is allowed; 5.Those who are known to be allergic to active ingredients or excipients such as Sintilimab, Etoposide, Carboplatin, Cisplatin, etc.; 6.Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 7.Untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center); 8.Active HCV infected subjects (HCV antibody is positive and HCV-RNA level is higher than the lower limit of detection); 9.There are any serious or uncontrollable systemic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Disease control rate;Duration of remission;Adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactZhao Lei
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed