Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151743
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-11-22
Brief Title:
Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal Carcinoma
Sponsor:
Eye ENT Hospital of Fudan University
Organization:
Eye ENT Hospital of Fudan University
Study Overview
Official Title:
Neoadjuvant Therapy With Toripalimab Combined With Cetuximab and Platinum for Resectable Locally Advanced Hypopharyngeal Cancer
Status:
RECRUITING
Status Verified Date:
2023-11
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:
The purpose of this clinical trial is to evaluate the efficacy and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal cancer Participants will receive three cycles of TPC neoadjuvant therapy toripalimab cetuximab platinum radical surgery laryngeal preservation surgery if possible and sequential chemoradiotherapy treatment after surgery This trial aims to answer the following questions
1 pCR rate
2 MPR rate ORR LPRDFSOS rare at 1 and 2 years
3 Safety and quality of life
1 pCR rate
2 MPR rate ORR LPRDFSOS rare at 1 and 2 years
3 Safety and quality of life
Detailed Description:
The standard treatment for patients with resectable hypopharyngeal carcinoma is surgery plus postoperative adjuvant radiotherapy or chemoradiotherapy Growing evidence shows that neoadjuvant therapy may significantly increase pCR in locally advanced SCCHN patients potentially improving patient survival The development of drugs immunotherapy and targeted therapy has been proven to improve the overall survival of patients with SCCHN significantly and PD-1 inhibitor combined with cetuximab has also shown promising efficacy in RM SCCHN This study explores the effectiveness and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal 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