Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05993858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-15
First Post:
2023-07-19
Brief Title:
Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced HNSCC
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Single-Center Single-Arm Exploratory Clinical Trial of Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
PC-1
Brief Summary:
This is a single-center single-arm phase II clinical study to evaluate the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC
Detailed Description:
At present the standard treatment for patients with operable locally advanced head and neck squamous cell carcinoma HNSCC is adjuvant radiotherapy with or without platinum-based synchronous chemotherapy after operation However the risk of recurrence metastasis and death remains high in this population with this intense combination treatment regimen Both EGFR monoclonal antibody and PD-1 inhibitors have proven the effect in advanced HNSCC At the same time cetuximab and PD-1 inhibitors have been reported to have a synergistic effect that may improve patient survival This study aims to explore the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC
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