Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05446467
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2022-06-30
Brief Title:
Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
Sponsor:
Zhejiang Provincial Peoples Hospital
Organization:
Zhejiang Provincial Peoples Hospital
Study Overview
Official Title:
Safety and Efficacy of Pembrolizumab in Combination With Low-dose PF Cisplatin and 5-Fluorouracil as Neoadjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma a Multi-center Single-arm Clinical Study Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
A phase Ⅱ open label multi-cencter clinical trail to evaluate the efficacy and safety of pembrolizumab combined with low-dose PF cisplatin 5-fluorouracil in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma
Detailed Description:
The investigatorsdesigned a multi-center single-arm small sample clinical pilot study In the clinical trial patients were given regimes of induction therapy with PLPF Pembrolizumab Low dose- P Platinum F 5-Fluorouracil 6 cycles of Pembrolizumab treatment Herein the investigators describe eight consecutive unselected LA SCCHN Locally Advanced Head and Neck Squamous Cell Carcinoma patients based on 6 completed cycles of PLPF induction therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None