Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009861
Status:
RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-08-16
Brief Title:
Neoadjuvant Tislelizumab Plus Chemotherapy for Locally Advanced OralOropharyngeal Cancer NeoSPOT
Sponsor:
Peking University Hospital of Stomatology
Organization:
Peking University Hospital of Stomatology
Study Overview
Official Title:
Neoadjuvant Chemoimmunotherapy With Tislelizumab Albumin-bound Paclitaxel and Cisplatin in Locally Advanced OralOropharyngeal Squamous Cell Carcinoma A Prospective Multicenter Single-arm Study
Status:
RECRUITING
Status Verified Date:
2023-08
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:
Previous studies confirmed locally advanced oraloropharyngeal squamous cell carcinoma LA OSCC or OPSCC patients with a pathological response had higher probability of survival in neoadjuvant settings Several ongoing trials of neoadjuvant immunotherapy in head and neck cancer showed promising results However the optimal regimen remains unclear This trial aimed to evaluate the efficacy and safety of neoadjuvant therapy with anti-programmed cell death 1 monoclonal antibody Tislelizumab and chemotherapy followed by surgery and adjuvant radiotherapy or chemoradiotherapy plus Tislelizumab in LA OSCC or OPSCC
Detailed Description:
None
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