Actively Recruiting
Safety and Efficacy of Pucotenlimab in pLECC
Led by Sun Yat-sen University · Updated on 2025-05-15
33
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Pucotenlimab in pLECC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 18 years old
- ECOG performance status score of 0 to 1
- Histopathologically confirmed locally advanced or metastatic lymphoepithelioma-like carcinoma in children or adolescents
- At least one measurable lesion by RECIST or WHO criteria
- Estimated survival time of 6 months or longer
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography
- Electrocardiogram (EKG) shows no signs of myocardial ischemia
- No history of arrhythmia requiring drug treatment before enrollment
- No history of severe immune-related adverse events (Grade 3 or 4)
- For patients without bone marrow involvement: absolute neutrophil count (ANC) at least 1.0 x 10^9/L
- Platelet count at least 100.0 x 10^9/L
- Hemoglobin 90 g/L or higher
- Liver and kidney function within specified limits including bilirubin ≤ 2.5 times upper limit of normal
- Able to comply with outpatient treatment, lab monitoring, and clinical visits
- Parent or guardian able to understand and sign informed consent, and child able to consent if applicable
You will not qualify if you...
- Previous treatment with anti-PD-1, anti-PD-L1 antibodies, or related targeted drugs
- Known allergy to PD-1 monoclonal antibody or its components
- History of severe allergic conditions or constitution
- Other malignant tumors except cured tumors without recurrence for 3 years, fully resected skin cancers, or in-situ cancers fully resected
- Active central nervous system metastases except stable asymptomatic brain metastases
- Uncontrollable pleural, pericardial effusion, or ascites requiring repeated drainage
- Previous treatment toxicity above Grade 1 except alopecia and neurotoxicity
- History of mental disorders or drug abuse
- History of idiopathic pulmonary fibrosis or pneumonia
- Need for immunosuppressive drugs or high-dose corticosteroids
- History of autoimmune diseases except certain controlled conditions
- History of active or previous tuberculosis infection
- Active infections requiring systemic treatment
- Uncontrolled hypertension, pulmonary hypertension, unstable angina, recent myocardial infarction, severe heart failure, valvular heart disease, or severe arrhythmias
- Severe medical comorbidities such as uncontrolled diabetes or active bleeding
- Positive for HIV, syphilis, hepatitis C antibodies, or active hepatitis B infection
- Abnormal thyroid function tests
- Expected to receive live or attenuated vaccines near treatment period
- Participation in another clinical trial with investigational drugs within 30 days
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yizhuo Zhang
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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