Small Cell Lung Cancer
Conditions
Interventions
case series:Sintilimab combined with concurrent chemoradiotherapy
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who signed the written informed consent before the implementation of any test related process; 2. Subjects aged >= 18 and 1L in lung function test; 8. Subjects without severe pulmonary interstitial disease confirmed by CT or PET / CT before treatment; 9. Subjects who could not receive any anti-tumor treatment for lung cancer in the past, but could accept thoracotomy, mediastinoscopy, resection biopsy or similar surgical operation to confirm the diagnosis, staging and surgical treatment of lung cancer. Patients with local or regional recurrence after previous pneumonectomy can also be enrolled if they meet other inclusion criteria (such as local time limit, unsuitable for further surgery). 10. For female subjects of childbearing age, they should be negative in urine or serum pregnancy test within 3 days before receiving the first study drug administration (cycle 1, day 1). If the urine pregnancy test results can not be confirmed as negative, blood pregnancy test is required. 11. Subjects with good hematopoietic function were defined as neutrophil absolute count >= 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, hemoglobin >= 90 g / L [no blood transfusion or EPO dependence within 7 days]; 12. Subjects with good liver function were defined as total bilirubin level = 60 ml / min (Cockcroft Gault formula); Urine routine examination showed that urine protein was negative or less than 2 +; 14. Subjects with good coagulation function were defined as international normalized ratio (INR) or prothrombin time (PT)<= 1.5 fold ULN; If the subject is receiving anticoagulant therapy, as long as Pt is within the scope of anticoagulant drugs; 15. Subjects whose myocardial enzymes are within the normal range; Note: simple laboratory abnormalities with no clinical significance can also be included in the study. 16. If there is a risk of pregnancy, male and female patients need to use effective contraception (i.e. the annual failure rate is less than 1%) and continue to use it for at least 180 days after the trial treatment is stopped.
Exclusion criteria
Exclusion criteria: 1. Subjects who are currently participating in the intervention clinical research treatment or have received other research drugs or used research instruments within 4 weeks before the first administration; 2. Subjects currently undergoing other clinical trials; 3. Patients with small cell lung cancer and non-small cell lung cancer confirmed by histopathology; 4. Subjects who are active or have suffered from autoimmune diseases (in the past 2 years), or have a history of primary immunodeficiency; 5. Patients who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); Patients who received systemic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) with anti lung cancer indications within 2 weeks before the first administration, or received heavy surgery within 4 weeks before the first administration; 6. Patients with effusion in the third space with clinical symptoms, such as pericardial effusion, pleural effusion and peritoneal effusion which can not be controlled by pumping or other treatment; 7. Patients with clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction; 8. Patients with active infection requiring systemic treatment; 9. Patients who have received solid organ or blood system transplantation; 10. Patients who are known to be allergic to etoposide, cisplatin, carboplatin, sindilimab components and or any excipients; 11. Active autoimmune diseases occurred in patients requiring systemic treatment (e.g. using disease relief drugs, corticosteroids or immunosuppressants) within 2 years before the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic; The patient was diagnosed with immunodeficiency or was receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the study. Physiological dose of Glucocorticoid (<= 10 mg / day of prednisone or equivalent) was allowed; 12. Patients diagnosed with other malignancies within 5 years before the first administration, with the exception of radical basal cell carcinoma of skin, squamous cell carcinoma of skin and / or radical resection of carcinoma in situ; 13. Patients with history of non infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease within 1 year before the first administration of glucocorticoid; 14. Patients with known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive); 15. Patients with positive HBsAg and HBV DNA detection value exceeding the upper limit of normal value (1000 copies / ml or 500 IU / ml); 16. Patients with known mental illness or drug abuse that may affect compliance with the trial requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactWei Huang
Shandong Cancer Hospital
Outcome results
None listed