Introduction
death, cancer, killer/T-cell lymphoma, anaplastic ependymomas, recurrent/advanced cancer, ENKTL
CANCER, MALIGNANCIES, MESENCHYMAL MALIGNANT TUMOR, NK/T-CELL LYMPHOMA, PEDIATRIC CANCER
In the past few years, immune checkpoint inhibitors (ICIs), particularly programmed cell death protein 1 (PD-1) or programmed cell death protein ligand 1 (PD-L1), have brought advancements to adult cancer treatment, resulting in remarkable breakthroughs.Currently, there is limited data regarding the effect of PD-1 antibodies in China, especially in pediatric populations. Prospective clinical trials have been conducted to explore the potential of inhibitors like pembrolizumab and nivolumab in the treatment of pediatric patients,Sintilimab, characterized as a fully humanized immunoglobulin G4 anti-PD-1 monoclonal antibody, has demonstrated promising anti-tumor activity and a favorable safety profile across various malignancies. Notably, it has demonstrated significant clinical advancements in NK/T-cell lymphoma. In the ORIENT-4 trial, Tao et al. found that sintilimab exhibited effectiveness and favorable tolerability in patients with relapsed/refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL), suggesting its potential as an innovative therapeutic strategy for managing ENKTL.It is crucial to emphasize the significance of domestically produced PD-1 antibodies in meeting the requirements of pediatric patients. In this article, we conducted a phase I study of sintilimab in children with recurrent/advanced cancer, including 10 HL, 3 mesenchymal malignant tumors, 2 anaplastic ependymomas, and some unique pathological types. The genomic landscape of patients treated with sintilimab was also evaluated. This in-depth exploration provides valuable information about the underlying biology and potential biomarkers associated with treatment response. Previous research has not extensively investigated the use of sintilimab in this particular patient population. To our knowledge, this represents the initial prospective clinical investigation of sintilimab in pediatric patients diagnosed with advanced malignancies. Sintilimab exhibited a satisfactory overall safety profile without encountering any DLTs, and objective clinical responses were observed at each administered dose level. Our study provides unique insights into the potential of sintilimab as a treatment option for pediatric cancer and lays a foundation for future combined PD-1 antibody applications.