Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605131
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
GP Combined with Toripalimab Versus GP Induction Chemotherapy for Advanced Childhood Nasopharyngeal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gemcitabine and Cisplatin in Combination with Toripalimab or Not As First-line Treatment in Advanced Childhood Nasopharyngeal Carcinoma an Open Randomised Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nasopharyngeal carcinoma NPC has a low incidence rate in children accounting for only 1-2 of pediatric tumors However it is prone to metastasis and most patients are already in advanced stages at the time of diagnosis Chemoradiotherapy has been shown to effectively improve prognosis Induction chemotherapy combined with concurrent chemoradiotherapy with adjusted radiation doses has demonstrated good efficacy in children and adolescents with locally advanced NPC Nevertheless 10-15 of patients still experience treatment failure and 15-20 of patients respond poorly to induction chemotherapy necessitating higher doses of radiation which in turn increases the incidence of treatment-related sequelae Therefore it is crucial to explore further treatment strategies that can enhance response rates reduce acute and long-term treatment toxicities and improve overall efficacy on the basis of induction chemotherapy followed by adjusted concurrent chemoradiotherapy
The combination of gemcitabine and cisplatin GP regimen has been identified as the highest level of evidence-based induction chemotherapy regimen Class 1A However the complete response rate of only 10 after three cycles of GP regimen induction chemotherapy in adults with locoregionally advanced NPC indicates the need for intensified induction treatment PD-1 inhibitors combined with chemotherapy have demonstrated synergistic tumor-killing effects providing additional curative opportunities for patients with locally advanced disease Toripalimab with its dual-blocking mechanism is an ideal PD-1 monoclonal antibody model that can fully relieve T-cell-mediated antitumor immune suppression Previous clinical trials have confirmed the efficacy and safety of toripalimab in treating nasopharyngeal carcinoma
This study aims to conduct the first single-center phase II randomized controlled clinical trial in children and adolescents with nasopharyngeal carcinoma comparing the GP regimen combined with toripalimab induction chemotherapy versus the GP regimen alone The goal is to optimize the treatment model for pediatric and adolescent NPC enhance therapeutic efficacy and provide high-level evidence-based medical support for the international treatment guidelines for pediatric NPC
The combination of gemcitabine and cisplatin GP regimen has been identified as the highest level of evidence-based induction chemotherapy regimen Class 1A However the complete response rate of only 10 after three cycles of GP regimen induction chemotherapy in adults with locoregionally advanced NPC indicates the need for intensified induction treatment PD-1 inhibitors combined with chemotherapy have demonstrated synergistic tumor-killing effects providing additional curative opportunities for patients with locally advanced disease Toripalimab with its dual-blocking mechanism is an ideal PD-1 monoclonal antibody model that can fully relieve T-cell-mediated antitumor immune suppression Previous clinical trials have confirmed the efficacy and safety of toripalimab in treating nasopharyngeal carcinoma
This study aims to conduct the first single-center phase II randomized controlled clinical trial in children and adolescents with nasopharyngeal carcinoma comparing the GP regimen combined with toripalimab induction chemotherapy versus the GP regimen alone The goal is to optimize the treatment model for pediatric and adolescent NPC enhance therapeutic efficacy and provide high-level evidence-based medical support for the international treatment guidelines for pediatric NPC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None