SCLC
Conditions
Interventions
experimental group:Induction therapy with tislelizumab combined with platinum-based drugs and etoposide (tislelizumab 200mg, IV, d1, Q3W
carboplatin AUC5 or cisplatin 75mg/? D1
etoposide 100mg/? D1-3), concurrent cranial radiotherapy 30Gy/10f/once daily. After the induction therapy phase, imaging is reviewed, and patients with CR/PR/SD efficacy evaluation enter the maintenan
temozolomide capsules PO, 200mg/m2/D, qd, d1-5, q4w). Maintenance therapy continues until disease progression, no clinical benefit, or intolerable toxicity, whichever occurs first.
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria may be considered for enrollment: Disease-related inclusion criteria: 1. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC); 2. Radiologically confirmed intracranial brain metastases (with or without symptoms); 3. ECOG PS: 0-1; 4. Expected survival greater than 3 months with adequate organ function reserves; Hematological, biochemical, and organ function criteria (results must be confirmed within 7 days before the first dose): 5. Absolute neutrophil count (ANC) >= 1.0×10^9/L, platelets >= 100×10^9/L, hemoglobin >= 80g/L; 6. International normalized ratio (INR) or prothrombin time (PT) = 60mL/min; 11. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= 50%; General inclusion criteria: 12. Able to provide written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule; 13. Male or female aged 18-75 years at the time of signing the ICF.
Exclusion criteria
Exclusion criteria: 1. Previously received platinum-based doublet chemotherapy for extensive-stage disease; 2. Previously received EGFR TKIs (such as erlotinib, gefitinib, icotinib, osimertinib, etc.) or ALK TKIs (such as crizotinib, alectinib, ceritinib, etc.); 3. Patients who have previously received immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4; 4. Previously received anlotinib or other anti-angiogenic therapy; 5. Previously received approved systemic anti-cancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor); 6. Patients with NSCLC (including mixed SCLC and NSCLC lung cancer); 7. Patients with refractory pleural effusion or ascites; 8. Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QTc = 480ms), and = grade 2 congestive heart failure (New York Heart Association [NYHA] classification); **Exclusion criteria related to study drugs:** 9. Allergic to any study drug or excipients; 10. Patients with active viral hepatitis who are judged by the investigator to require treatment; 11. Renal failure requiring hemodialysis or peritoneal dialysis; 12. Urinalysis indicating proteinuria >= ++, and confirmed 24-hour urine protein quantification > 1.0g; 13. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection: a. Severe infection requiring hospitalization within 4 weeks before the first dose, including but not limited to infection complications, bacteremia, or severe pneumonia; b. Oral or intravenous antibiotic treatment within 2 weeks before the first dose; 14. Previously received targeted immune checkpoint pathway antibodies or drugs, including but not limited to anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies; 15. Use of systemic immune stimulants (including but not limited to interferon, interleukin-2, tumor necrosis factor) within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is longer) (previous use of cancer vaccines is allowed); 16. Use of any herbal medicine for cancer control within 14 days before the first dose of the study drug; 17. Any disease requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive drugs within 14 days before enrollment; Note: Patients who have used any of the following steroid regimens currently or in the past may be enrolled: - Adrenal replacement steroids (prednisone <= 10 mg/day or equivalent); - Local, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; - Short-term (<= 7 days) prophylactic use of prescription corticosteroids (e.g., for contrast agent allergy) or for the treatment of non-autoimmune diseases (e.g., delayed-type hypersensitivity reactions caused by contact allergens); 18. Live vaccine within <= 4 weeks before enrollment; 19. Previous allogeneic stem cell transplantation or organ transplantation; 20. Clinically significant pericardial effusion; 21. Clinically uncontrolled pleural effusion or ascites requiring thoracentesis or paracentesis within 2 weeks before enrollment; 22. Patients with active autoimmune diseases or a history of autoimmune diseases that may recur; Note: The following patients are not excluded and may be further screened: - Well-controlled type 1 diabetes; - Hypothyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-Month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month PFS rate;median progression free survival;Intracranial Progression-free Survival;Overall survival;Safety;Objective response rate;Disease control rate;Duration of response; | — |
Countries
China
Contacts
Public ContactWang Haiyong
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed