Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-C
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. Add
| Condition(s) | Limited-stage Small Cell Lung Cancer (LS-SCLC) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 (A |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Peking University Cancer Hospital & Institute |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2025-02-25 |
| NCT ID | NCT06869239 |
| Official listing | https://clinicaltrials.gov/study/NCT06869239 |