Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537011
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Phase II Study of Neoadjuvant Treatment With AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them
Detailed Description:
This exploratory phase II study is designed to enroll 36 patients with operable locally advanced head and neck squamous cell carcinomadefined according to 8th teh edition of AJCC Guideline The patients are given 3cycles of AK11220mgKg per cycle combined with AP regimenplatinum based chemotherapy with a 3-week interval between each cycle d1d22d43 After 3 cycles therapy if the volume of primary tumor decreases by over 50the range of resection operation will be conducted by the actual range of tumor or else the surgery will be conducted by the original range of the tumor The adjuvant radiation therapy would be conducted in 4-6 weeks after the surgery while the adjuvant therapy of AK112 would be given in 21days after the surgery for 14 cycles The process will continue until disease progression or uncontrolled toxicity The primary endpoint is pCRpathological complete response and 2y-EFS the secondary endpoint is MPRMain pathological responseORRobjective response rate2y-OSoverall survivalorgan retention rate and safety assessment
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