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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pucotenlimab combined with GP regimen
DrugA 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).
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Pucotenlimab plus a fixed regimen( Gemcitabine and cisplatin)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS
progression of the disease or the death
Time frame
PFS is defined as the time interval from the start of treatment until the occurrence of disease progression or death of the patient from any cause, whichever happens first (up to 24 months）.Secondary outcomes
1
ORR
The objective response rate is an important indicator for measuring the effect of a treatment regimen in shrinking tumors.Starting from the initiation of the combination therapy, regular imaging examinations (such as CT, MRI, etc.) and clinical evaluations of patients will be conducted.
Time frame
The objective response rate will be assessed over an estimated period of up to 3 months（after first 2 cycles, before the 3rd cycle, each cycle is 21 days).2
OS
Overall survival (OS) is defined as the time from the initiation of treatment with pucotenlimab in combination with the GP regimen until the patient's death from any cause. Death is determined based on official medical records or other reliable documentation. The follow - up for OS will continue throughout this estimated assessment period.
Time frame
The assessment of OS will be carried out over an estimated period of up to 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
Source ClinicalTrials.gov