Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05941338
Status:
RECRUITING
Last Update Posted:
2023-07-12
First Post:
2023-06-05
Brief Title:
Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Prospective One-arm Phase II Clinical Study of Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in Patients With Resectable Squamous Cell Carcinoma of the Head and Neck
Status:
RECRUITING
Status Verified Date:
2023-03
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:
HNC-SYSU-001
Brief Summary:
In this study 100 patients with resectable head and neck squamous cell carcinoma oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma were enrolled who were combined with tirelizumab carboplatin and albumin-binding paclitaxel before and after surgery Tumor tissues and paracancer tissues of patients were collected to observe the imaging and pathological changes before and after treatment At the same time clinical information of patients such as pathological grade stage treatment prognosis serology imaging etc were collected to evaluate the safety and feasibility of tirelizumab combined with carboplatin and albumin-binding paclitaxel for neoadjuvant therapy of resectable oral and oropharyngeal squamous cell carcinoma This is a prospective one-arm phase II clinical study
Purpose Main purpose The efficacy of Tirelizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma was evaluated by calculating the major pathological response MPR rates in the experimental group
The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE version 50 during the course of this study and during follow-up the incidence of adverse events in the experimental and control groups will be compared and the safety of neoadjuvant therapy with Tirelizumab combined with carboplatin and albumin-paclitaxel in resectable head and neck squamous cell carcinoma will be evaluated
Secondary Purpose
1 One-year event survival rate and event-free survival EFS of enrolled patients were evaluated five years
2 Pathological complete response rate pCR of enrolled patients was evaluated 5 years
3 pTR of enrolled patients was evaluated
4 Overall survival OS of enrolled patients was evaluated 5 years
5 Radiological response of enrolled patients was assessed
6 The rate of operation delay of enrolled patients was evaluated
Purpose Main purpose The efficacy of Tirelizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma was evaluated by calculating the major pathological response MPR rates in the experimental group
The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE version 50 during the course of this study and during follow-up the incidence of adverse events in the experimental and control groups will be compared and the safety of neoadjuvant therapy with Tirelizumab combined with carboplatin and albumin-paclitaxel in resectable head and neck squamous cell carcinoma will be evaluated
Secondary Purpose
1 One-year event survival rate and event-free survival EFS of enrolled patients were evaluated five years
2 Pathological complete response rate pCR of enrolled patients was evaluated 5 years
3 pTR of enrolled patients was evaluated
4 Overall survival OS of enrolled patients was evaluated 5 years
5 Radiological response of enrolled patients was assessed
6 The rate of operation delay of enrolled patients was evaluated
Detailed Description:
None
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