Safety and Efficacy of Pucotenlimab in pLECC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
Age: Between 1 and 18 years old;
ECOG PS score: 0 to 1 point;
Histopathologically confirmed locally advanced or metastatic lymphoepithelioma-like carcinoma in children or adolescents;
Must have at least one measurable lesion defined by the RECIST or WHO criteria;
Disqualifiers
Have received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs of related pathways;
Known to be allergic to PD-1 monoclonal antibody or any of its excipients; Known to have a history of allergic diseases or have a severe allergic constitution;
Have other malignant tumor diseases other than the tumor being treated in this study, except for: Malignant tumors that have been cured and have not recurred within 3 years before study enrollment, completely resected basal cell and squamous cell skin cancers, and any type of in-situ cancer that has been completely resected;
Active central nervous system metastases (whether treated or not), including symptomatic brain metastases, meningeal metastases, spinal cord compression, etc.; Except for: Asymptomatic brain metastases (no progression within at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after surgical resection, and no need for dexamethasone or mannitol treatment).
Trial design
Treatments tested in this trial
- Pucotenlimab combined with GP regimen
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
Source ClinicalTrials.gov