Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-29 @ 6:04 AM
Study NCT ID:
NCT06969534
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Pucotenlimab in pLECC
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Phase II Clinical Study on the Safety and Efficacy of Pucotenlimab Combined With the Chemotherapy Regimen of Gemcitabine and Cisplatin for Lymphoepithelioma-like Carcinoma in Children and Adolescents
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Lymphoepithelioma-like carcinoma (LELC) in children is a rare epithelial malignant tumor, and its most prominent feature is the presence of a large number of tumor infiltrating lymphocytes (TILs) in the tumor background. LELC can occur in various organs of the digestive, respiratory, skin, urinary, reproductive and other systems, but it is most commonly found in the lungs, salivary glands and stomach. In children, the common sites of LELC are the thymus, parotid gland, lymph nodes and other parts. Clinically, there is no standard treatment guideline for LELC, and currently, the same treatment regimens as those for other tumors in the same system are mostly used. At present, there is a lack of systematic reports on pediatric lymphoepithelioma-like carcinoma (pLELC), and most of the known reports are case studies.
For pediatric lymphoepithelioma-like carcinoma (pLELC), its clinicopathological features, prognosis and molecular characteristics remain unknown. Previously published research of the investigators showed that in preclinical studies, the clinical features and prognosis of pLELC were reported, and a retrospective study explored the real-world efficacy data of the investigators' center over more than 10 years. Kaplan-Meier survival analysis for children and adolescents showed that for patients who only received chemotherapy, the 1-year progression-free survival (PFS) was 60.72% (95% CI: 45.07% - 81.79%), and the 2-year progression-free survival was 56.92% (95% CI: 41.18% - 78.68%). The 1-year overall survival (OS) of the patients was 96.4% (95% CI: 89.79% - 100%), and the 2-year overall survival was 76.53% (95% CI: 61.66% - 95.00%).
For the group treated with PD-1 inhibitor combined with chemotherapy, only 1 patient (1/10) died due to disease progression. Kaplan-Meier survival analysis showed that for patients who received anti-PD-1 combined with chemotherapy, the 1-year progression-free survival was 100%, and the 2-year progression-free survival was 72.92% (95% CI: 46.80% - 100%). In addition, the 1-year overall survival of patients who received anti-PD-1 combined with chemotherapy was 100%, and the 2-year overall survival was 87.5% (95% CI: 67.34% - 100%). Both the median progression-free survival and the median overall survival have not been reached.
In addition, the investigators determined its genomic landscape through whole exome sequencing (WES), including single nucleotide variants (SNVs) and copy number variants (CNVs). Furthermore, the investigators comprehensively compared the genomic landscape of pLELC with other related cancer types (such as nasopharyngeal carcinoma in children and adult LELC) to further deepen understanding of this malignant tumor.
The preclinical data provide a theoretical basis for the immunotherapy with PD-1 antibody for pediatric lymphoepithelioma-like carcinoma.
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.
For pediatric lymphoepithelioma-like carcinoma (pLELC), its clinicopathological features, prognosis and molecular characteristics remain unknown. Previously published research of the investigators showed that in preclinical studies, the clinical features and prognosis of pLELC were reported, and a retrospective study explored the real-world efficacy data of the investigators' center over more than 10 years. Kaplan-Meier survival analysis for children and adolescents showed that for patients who only received chemotherapy, the 1-year progression-free survival (PFS) was 60.72% (95% CI: 45.07% - 81.79%), and the 2-year progression-free survival was 56.92% (95% CI: 41.18% - 78.68%). The 1-year overall survival (OS) of the patients was 96.4% (95% CI: 89.79% - 100%), and the 2-year overall survival was 76.53% (95% CI: 61.66% - 95.00%).
For the group treated with PD-1 inhibitor combined with chemotherapy, only 1 patient (1/10) died due to disease progression. Kaplan-Meier survival analysis showed that for patients who received anti-PD-1 combined with chemotherapy, the 1-year progression-free survival was 100%, and the 2-year progression-free survival was 72.92% (95% CI: 46.80% - 100%). In addition, the 1-year overall survival of patients who received anti-PD-1 combined with chemotherapy was 100%, and the 2-year overall survival was 87.5% (95% CI: 67.34% - 100%). Both the median progression-free survival and the median overall survival have not been reached.
In addition, the investigators determined its genomic landscape through whole exome sequencing (WES), including single nucleotide variants (SNVs) and copy number variants (CNVs). Furthermore, the investigators comprehensively compared the genomic landscape of pLELC with other related cancer types (such as nasopharyngeal carcinoma in children and adult LELC) to further deepen understanding of this malignant tumor.
The preclinical data provide a theoretical basis for the immunotherapy with PD-1 antibody for pediatric lymphoepithelioma-like carcinoma.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: