Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647563
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Neoadjuvant Toripalimab Chemotherapy Cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma Neo-ICT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Study of Toripalimab Combined With Chemotherapy or With ChemotherapyCetuximab as Neoadjuvant Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck Neo-ICT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized active-controlled open-label clinical trial for participants with newly diagnosed Stage III-IVb resectable locoregionally advanced head and neck squamous cell carcinoma LA-HNSCC The study consists of two experimental arms and one control arm Participants in Experimental Arm A will receive two cycles of Toripalimab albumin-bound paclitaxel carboplatin and cetuximab prior to surgery Participants in Experimental Arm B will receive two cycles of Toripalimab albumin-bound paclitaxel and carboplatin before surgical intervention Following the surgical procedure individuals in both Experimental Arm A and B will continue to receive 15 cycles of Toripalimab The Control Arm will undergo the current standard treatment without preoperative drug intervention Postoperatively participants will be administered postoperative radiotherapy or chemoradiotherapy based on their recurrence risk The primary study hypotheses are that the treatments in the Experimental Arms will improve the 2-year event-free survival EFS rates compared to the standard control treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None