Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125223
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-10-31
Brief Title:
PABLIXIMAB as Neoadjuvant Therapy for Head and Neck Squamous-cell Carcinoma
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
A Single-arm Prospective Phase II Study of PABLIXIMAB Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous-cell Carcinoma
Status:
NOT_YET_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 goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
The main question it aims to answer is Pathological complete remission PCR rate of tumor after neoadjuvant immunotherapy
Participants will be asked to perform CT and MRI of head and neck ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy And will be following-up for at least 1 year
The main question it aims to answer is Pathological complete remission PCR rate of tumor after neoadjuvant immunotherapy
Participants will be asked to perform CT and MRI of head and neck ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy And will be following-up for at least 1 year
Detailed Description:
The secondary questions it aims to answer are
Objective response rate ORR after neoadjuvant therapy
R0 resection rate
major pathological remission MPR rate
organ preservation rate
event-free survival EFS
local recurrence-free survival LRFS
distant metastasis-free survival DMFS
quality of life score QoL
overall survival OS
incidence of adverse events including neoadjuvant stage AEs and full course AEs The exploratory question it aims to answer is clearance of peripheral blood ctDNA
Objective response rate ORR after neoadjuvant therapy
R0 resection rate
major pathological remission MPR rate
organ preservation rate
event-free survival EFS
local recurrence-free survival LRFS
distant metastasis-free survival DMFS
quality of life score QoL
overall survival OS
incidence of adverse events including neoadjuvant stage AEs and full course AEs The exploratory question it aims to answer is clearance of peripheral blood ctDNA
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?:
False
Is an FDA AA801 Violation?:
None