Safety and Efficacy of Pucotenlimab in pLECC
Trial Parameters
Brief Summary
Lymphoepithelioma-like carcinoma (LELC) in children is a rare epithelial malignant tumor. Regarding pediatric lymphoepithelioma-like carcinoma (pLELC), its clinicopathological features, prognosis, and molecular characteristics remain unknown. In preclinical studies, this study aims to explore the safety and efficacy of the PD-1 monoclonal antibody pucotenlimab combined with the chemotherapy regimen of gemcitabine and cisplatin as the first-line treatment for lymphoepithelioma-like carcinoma in children and adolescents.
Eligibility Criteria
Inclusion Criteria: * Age: Between 1 and 18 years old; * ECOG PS score: 0 to 1 point; * Histopathologically confirmed locally advanced or metastatic lymphoepithelioma-like carcinoma in children or adolescents; * Must have at least one measurable lesion defined by the RECIST or WHO criteria; * Estimated survival time ≥ 6 months; * Cardiac function:Left ventricular ejection fraction (LVEF) detected by echocardiography ≥ 50%; Electrocardiogram (EKG) shows no signs of myocardial ischemia; * No history of arrhythmia requiring drug intervention before enrollment; * No history of severe immune-related adverse events (CTCAE V4.03 Grade 3 or Grade 4); * For patients known not to have bone marrow (BM) involvement:Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L; Platelet count ≥ 100.0×10⁹/L;Hemoglobin ≥ 90 g/L; * Liver and kidney functions should meet the following criteria: Total bilirubin (conjugated + unconjugated) ≤ 2.5× the upper limit of normal value (ULN) (corresponding to the age). Patients w