Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-29 @ 5:52 PM
Study NCT ID:
NCT05993858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-15
First Post:
2023-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced HNSCC
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
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?: