small cell lung cancer
Conditions
Interventions
single group:Sintilimab+Irinotecan
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who sign the informed consent form prior to the implementation of any trial-related process; 2. Patients aged >= 18 years and 3 months; 4. Patients who have at least one measurable lesion confirmed by the investigator according to RECIST 1.1; 5. Patients with histologically or cytologically confirmed, extensive-stage small-cell lung cancer without brain metastasis according to the 8th edition of Lung Cancer TNM Staging of the International Association for the Study of Lung Cancer (IASLC); Brain CT/MRI examination should be performed before study inclusion during screening; 6. Patients who can provide archived tumor mass or at least 10 freshly cut unstained slices; 7. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 8. Patients who can provide tumor sample for PD-L1 testing. Recent testing reports from renowned organization are allowed; A second aspiration biopsy is required if the time interval from first biopsy is longer than 6 months; 9. Patients with extensive-stage SCLC who progressed or relapsed after first-line EP regimen therapy within 6 months; 10. Patients with good hematopoietic function, defined as absolute white blood cell count >= 4*10^9/L, neutrophil count>=1.5*10^9 /L, platelet count >= 100*10^9 /L, and hemoglobin>=90 g/L [without blood transfusion or no promoting hematopoietic drugs were used within 7 days]; 11. Patients with good liver function, defined as total bilirubin =60 ml/min.
Exclusion criteria
Exclusion criteria: 1. Personnel involved in the design and/or implementation of the study. 2. Patients who are currently participating in an interventional clinical study treatment or have received other study drugs or have been treated with a study device within 4 weeks prior to the first dose; 3. Patients who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeted at another stimulus or co-inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Patients who have previously received systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, and interleukin, with the except for topical use for control of pleural effusion) within 2 weeks prior to the first dose, or major surgical treatment within 3 weeks prior to the first dose; 5. Patients who have received pulmonary radiation therapy > 30 Gy within 6 months prior to the first dose; 6. Patients who have completed palliative radiation therapy within 7 days prior to the first dose; 7. Patients with clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction; 8. Patients who have received physical organ or blood system transplantation; 9. Patients with clinically uncontrollable pleural effusion/abdominal effusion; 10. Patients known to have severe (grade >= 3) allergic reactions to active ingredients and/or any excipients of Sintilimab, irinotecan and or other accessory ingredients; 11. Patients who have suffered from active autoimmune diseases requiring systemic treatment (e.g., use of drugs for remission, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic therapy; 12. Patients diagnosed as immunodeficient or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study. Physiological doses of glucocorticoids (<= 10 mg/day prednisone or equivalent) are allowed; 13. Patients who have not fully recovered from toxicity and/or complications from any intervention (i.e., <= grade 1 or reaching baseline, excluding fatigue or hair loss) prior to initiation of treatment; 14. Patients diagnosed with other malignant tumors within 5 years prior to the first dose, with exceptions including radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ; 15. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases; 16. Patients with a history of non-infective pneumonia requiring glucocorticoid therapy within 1 year prior to the first dose or currently suffering from interstitial lung diseases; 17. Patients with active infections requiring systemic treatment; 18. Patients known to possibly have mental illnesses or substance abuse that may affect the compliance with the trial requirements; 19. Patients known to have a history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 20. Patients with untreated active hepatitis B; Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: Before the first dose, the HBV viral load must be <1000 copies/ml (200 IU/ml). Subjects should receive anti-HBV therapy to av
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression free survival;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactYu Zhang
Department of Oncology, Affiliated Hospital of Qingdao University
Outcome results
None listed