Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05980702
Status:
RECRUITING
Last Update Posted:
2023-09-07
First Post:
2023-06-05
Brief Title:
4 Courses vs 2 Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel of 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:
Safety and Efficacy of Four Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel Versus Two Courses of Neoadjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma T3 or T4 N0 An Optimal Efficacy Study Prospective Two-arm Phase II
Status:
RECRUITING
Status Verified Date:
2023-09
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-002
Brief Summary:
In this study 200 patients with resectable head and neck squamous cell carcinoma T3 or T4 N0 were enrolled and preoperatively combined with pembrolizumab PD-1 inhibitor carboplatin and albumin-binding paclitaxel The subjects were randomly divided 11 into four treatments and two treatments The imaging and pathological changes of tumor and paracancer tissues before and after treatment were observed Clinical information such as pathological grade stage treatment prognosis serology imaging etc was collected to evaluate the safety and efficacy of 4-course pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with 2-course neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma This is a prospective one-arm phase II clinical study
Main purpose By calculating pathological complete response pCR in the experimental group we evaluated the efficacy optimality of four courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with two courses of neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma T3 or T4 N0
At the same time this study evaluated the safety of medication specifically The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE version 50 during this study and during follow-up and the occurrence of adverse events in the experimental and control groups will be compared To evaluate the safety of 4-course Pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with 2-course neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma T3 or T4 N0
Secondary Purpose
1 The event-free survival EFS of the two groups were compared
2 The main pathological response rate MPR of the two groups were compared
3 pTR of the two groups was compared
4 Overall survival OS of the two groups was compared
5 The radiological responses of the two groups were compared
6 The operation delay rate of the two groups was compared Exploratory purpose For the response of enrolled patients after treatment group treatment was conducted according to the guidelines and stratified factors influencing the prognosis and treatment plan of immunotherapy were explored according to stratification The stratification factors taken into consideration are P16 status smoking history TNM stage tumor reduction MPR condition presence of risk factors according to the guidelines risk factors are presence of episopercular invasion positive incisal margin proximal incisal margin pT3 or pT4 pN2 or pN3 lymph nodes located in the IV and V regions of the neck Nerve invasion vascular invasion etc The purpose of this study was to stratified risk factors for evaluating the efficacy of pembrolizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma At the same time hematological pathological and fecal indicators collected in the design of the experiment were collected Correlation analysis was conducted to statistically analyze the relationship between these indicators and the therapeutic effect of the program
Main purpose By calculating pathological complete response pCR in the experimental group we evaluated the efficacy optimality of four courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with two courses of neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma T3 or T4 N0
At the same time this study evaluated the safety of medication specifically The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE version 50 during this study and during follow-up and the occurrence of adverse events in the experimental and control groups will be compared To evaluate the safety of 4-course Pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with 2-course neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma T3 or T4 N0
Secondary Purpose
1 The event-free survival EFS of the two groups were compared
2 The main pathological response rate MPR of the two groups were compared
3 pTR of the two groups was compared
4 Overall survival OS of the two groups was compared
5 The radiological responses of the two groups were compared
6 The operation delay rate of the two groups was compared Exploratory purpose For the response of enrolled patients after treatment group treatment was conducted according to the guidelines and stratified factors influencing the prognosis and treatment plan of immunotherapy were explored according to stratification The stratification factors taken into consideration are P16 status smoking history TNM stage tumor reduction MPR condition presence of risk factors according to the guidelines risk factors are presence of episopercular invasion positive incisal margin proximal incisal margin pT3 or pT4 pN2 or pN3 lymph nodes located in the IV and V regions of the neck Nerve invasion vascular invasion etc The purpose of this study was to stratified risk factors for evaluating the efficacy of pembrolizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma At the same time hematological pathological and fecal indicators collected in the design of the experiment were collected Correlation analysis was conducted to statistically analyze the relationship between these indicators and the therapeutic effect of the program
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?:
None
Is an FDA AA801 Violation?:
None