Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490341
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Brief Title:
GP Combined With Nimotuzumab and Sintilimab as Induction Therapy for Nasopharyngeal Carcinoma
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Safety and Efficacy of GP Regimen Combined With Nimotuzumab and Sintilimab as Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma a Single-center Prospective Single-arm Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The goal of this clinical trial is to learn if the regimen of gemcitabine cisplatin combined with nimotuzumab and sintilimab works to treat locally advanced nasopharyngeal carcinoma before chemoradiotherapy It will also learn about the safety of the regimen The main questions it aims to answer are
Does the regimen increase the number of participants who has a significant tumor shrinkage
What medical problems do participants have when taking the regimen Researchers will evaluate the safety and efficacy of the regimen
Participants will
Take the regimen every 21 days for twice
Visit the clinic weekly for drug administration checkups and tests
Keep a diary of their symptoms
Does the regimen increase the number of participants who has a significant tumor shrinkage
What medical problems do participants have when taking the regimen Researchers will evaluate the safety and efficacy of the regimen
Participants will
Take the regimen every 21 days for twice
Visit the clinic weekly for drug administration checkups and tests
Keep a diary of their symptoms
Detailed Description:
The study is to investigate the efficacy and safety of combining nimotuzumab and sintilimab with the GP regimen for induction chemotherapy in patients with locally advanced nasopharyngeal carcinoma
This clinical trial adopts a single-center prospective single-arm phase II trial design Each treatment cycle will be three weeks long with a total of two cycles
After screening eligible patients will be enrolled in the study Patients will receive two cycles of gemcitabine cisplatin nimotuzumab and sintilimab as induction therapy Patients will undergo regular follow-up visits and researchers will collect data on efficacy and safety Short-term outcomes will be assessed according to the RECIST 11 criteria and adverse events will be evaluated using the CTCAE 50
This clinical trial adopts a single-center prospective single-arm phase II trial design Each treatment cycle will be three weeks long with a total of two cycles
After screening eligible patients will be enrolled in the study Patients will receive two cycles of gemcitabine cisplatin nimotuzumab and sintilimab as induction therapy Patients will undergo regular follow-up visits and researchers will collect data on efficacy and safety Short-term outcomes will be assessed according to the RECIST 11 criteria and adverse events will be evaluated using the CTCAE 50
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?:
None