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Safety and Efficacy of Pucotenlimab in pLECC

NCT06969534 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

  • Lymphoepithelioma-like Carcinoma
  • Lymphoepithelioma
  • Carcinoma

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).

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06969534 on ClinicalTrials.gov