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RECRUITING
NCT06969534
PHASE2

Safety and Efficacy of Pucotenlimab in pLECC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: Phase II Clinical Study on the Safety and Efficacy of Pucotenlimab Combined With the Chemotherapy Regimen of Gemcitabine and Cisplatin for Lymphoepithelioma-like Carcinoma in Children and Adolescents

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-05-15

Completion Date

2028-12-30

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DRUG

Pucotenlimab combined with GP regimen

A total of 33 cases are planned to be enrolled. All the subjects will receive Pucotenlimab (3mg/kg, on day 1, with a maximum dose not exceeding 200mg), administered once every 3 weeks (Q3W), and combined with the GP regimen. The chemotherapy is a fixed regimen, with Gemcitabine at a dose of 1g/m² on day 1 and day 8, and cisplatin at a dose of 80mg/m² on day 1. The chemotherapy will be given for 3 to 6 cycles, once every 3 weeks (Q3W).

Locations (1)

Yizhuo Zhang

Guangzhou, Guangdong, China