drugset / Trial / NCT06969534

Safety and Efficacy of Pucotenlimab in pLECC

NCT06969534

Phase 2 Recruiting 33 enrolled Sun Yat-sen University
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

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 80 mg/m2
Subject Gemcitabine Small molecule 1 g
Subject Pucotenlimab Monoclonal antibody 3 mg/kg