OncoMatch/Clinical Trials/NCT06969534
Safety and Efficacy of Pucotenlimab in pLECC
Is NCT06969534 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pucotenlimab combined with GP regimen for lymphoepithelioma-like carcinoma.
Treatment: Pucotenlimab combined with GP regimen — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Have received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs of related pathways
Cannot have received: anti-PD-L1 therapy
Have received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs of related pathways
Lab requirements
Blood counts
For patients known not to have bone marrow (BM) involvement: ANC ≥ 1.0×10⁹/L; Platelet count ≥ 100.0×10⁹/L; Hemoglobin ≥ 90 g/L
Kidney function
Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m² or serum creatinine (Cr) ≤ 1.5× ULN
Liver function
Total bilirubin (conjugated + unconjugated) ≤ 2.5× ULN (corresponding to the age). Patients with confirmed Gilbert's syndrome can be considered for enrollment at the discretion of the investigator; AST and ALT ≤ 2.5× ULN
Cardiac function
Left ventricular ejection fraction (LVEF) detected by echocardiography ≥ 50%; Electrocardiogram (EKG) shows no signs of myocardial ischemia; No history of arrhythmia requiring drug intervention before enrollment
Cardiac function: Left ventricular ejection fraction (LVEF) detected by echocardiography ≥ 50%; Electrocardiogram (EKG) shows no signs of myocardial ischemia; No history of arrhythmia requiring drug intervention before enrollment; Liver and kidney functions should meet the following criteria: Total bilirubin (conjugated + unconjugated) ≤ 2.5× ULN (corresponding to the age). Patients with confirmed Gilbert's syndrome can be considered for enrollment at the discretion of the investigator; AST and ALT ≤ 2.5× ULN; Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m² or serum creatinine (Cr) ≤ 1.5× ULN; For patients known not to have bone marrow (BM) involvement: ANC ≥ 1.0×10⁹/L; Platelet count ≥ 100.0×10⁹/L; Hemoglobin ≥ 90 g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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