A Prospective, Single Arm, Phase II Clinical Study of Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.
• Signed informed consent;
• Age 18-75 years;
• According to the judgment of the investigator, the patient was able to comply with the study protocol;
• Histologically or cytologically confirmed extensive stage small cell lung cancer (es-sclc) (according to the Veterans Administration lung cancer association \[valg\] staging system);
• No previous systemic treatment for ES-SCLC;
• With measurable lesions assessed by the investigator according to RECIST version 1.1;
• ECOG physical status score was 0 or 1;
• Life expectancy ≥ 3 months;
• Adequate hematology and end organ function, as defined by the following laboratory findings, which should be obtained within 14 days before the first study treatment: absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/l (without granulocyte colony-stimulating factor treatment); Lymphocyte count ≥ 0.5 × 10\^9/l (500 / μ L); Platelet count ≥ 100 × 10\^9/l (100000 / μ L); Hemoglobin ≥ 90g/l (9.0g/dl); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions: Patients with confirmed liver metastasis: AST and alt ≤ 5 × ULN; Patients with confirmed liver or bone metastasis: ALP ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN, with the following exceptions: patients known to have Gilbert syndrome: total bilirubin ≤ 3 × ULN; Creatinine clearance ≥ 60ml/min (calculated by Cockcroft Gault formula); Albumin ≥ 25g/l (2.5g/dl).