Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer Using Multi-omics-based Liquid Biopsy
Trial Parameters
Brief Summary
This study aims to explore the efficacy and safety of immunotherapy (PD-L1 inhibitor) maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer (LS-SCLC). This study is a prospective observational study. Additionally, liquid biopsy technology will be employed to identify biomarkers that can predict the efficacy of PD-L1 inhibitor after chemoradiotherapy in LS-SCLC.
Eligibility Criteria
Inclusion Criteria: * 1\. Age 18-75 years, male or female; * 2\. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) (AJCC, 8th edition); * 3\. No more than 2 cycles of chemotherapy or no previous systemic therapy; * 4\. ECOG PS 0-1; * 5\. Measurable disease, as defined by RECIST v1.1 (tumor lesions long axis≥10mm, lymph nodes short axis ≥15mm); * 6\. Life expectancy ≥3 months; * 7\. Adequate pulmonary function; * 8\. Adequate hematologic and end-organ function, defined by the following criteria: 1. Hematology * Hemoglobin (HGB) ≥90 g/L; * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; * Platelet count (PLT) ≥ 100 x 10\^9/L; * White blood cell count (WBC) ≥ 3.0 x 10\^9/L; 2. Serum chemistry * Serum albumin (ALB) ≥ 30 g/L; * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x ULN; * Total bilirubin (TBIL) ≤1.5 ULN; Note: Patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia \[mainly unconjugat