Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438627
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-24
Brief Title:
Efficacy and Safety of TPCApatinibCamrelizumab vs GP Camrelizumab for High-Risk Nasopharyngeal Carcinoma A Phase 3 Trial
Sponsor:
XIANG YANQUN
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Efficacy and Safety of Nab-Paclitaxel Cisplatin and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab vs Gemcitabine Cisplatin Combined With Camrelizumab for Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Nasopharyngeal Carcinoma A Prospective Controlled Open-Label Multicenter Phase 3 Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This study aims to evaluate the efficacy and safety of the TPC regimen nab-paclitaxel cisplatin and capecitabine combined with apatinib and camrelizumab versus the GP regimen gemcitabine and cisplatin combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis The evaluation will be conducted through a prospective controlled open-label multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma
Detailed Description:
IMPORTANCE Safe and effective therapies for untreated advanced locally advanced nasopharyngeal carcinoma remain an unmet need
OBJECTIVEThis study aims to evaluate the efficacy and safety of the TPC regimen nab-paclitaxel cisplatin and capecitabine combined with apatinib and camrelizumab versus the GP regimen gemcitabine and cisplatin combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis The evaluation will be conducted through a prospective controlled open-label multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma
OBJECTIVEThis study aims to evaluate the efficacy and safety of the TPC regimen nab-paclitaxel cisplatin and capecitabine combined with apatinib and camrelizumab versus the GP regimen gemcitabine and cisplatin combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis The evaluation will be conducted through a prospective controlled open-label multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma
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