drugset / Trial / NCT06969534
Safety and Efficacy of Pucotenlimab in pLECC
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-05-15
- Primary completion
- 2027-12-30
- Completion
- 2028-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1 g | — |
| Subject | Pucotenlimab | Monoclonal antibody | 3 mg/kg | — |