Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102395
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-04-12
Brief Title:
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced LA HNSCC
Sponsor:
Beijing Tongren Hospital
Organization:
Beijing Tongren Hospital
Study Overview
Official Title:
EFFECT-neo A Prospective Open-label Multicenter Phase III Study to Evaluate Efficacy and Safety of Pembrolizumab Combined With Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced LA HNSCC
Status:
RECRUITING
Status Verified Date:
2023-04
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:
This study is a prospective open-label multi-center phase III study patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma including oral cavity cancer oropharyngeal cancer hypopharyngeal cancer and laryngeal cancer who meet the inclusion criteria are randomized 11 and given pembrolizumab 200 mg d1 chemotherapy for 2 cycles experimental group 2 cycles of chemotherapy control group and then stratified according to the patients condition If the imaging evaluation after neoadjuvant treatment is complete response CR adjuvant radiotherapy will be given if the imaging evaluation is partial response PR or stable disease SD surgery within 2 weeks will be performed followed by standard treatment The main research hypothesis of this study pembrolizumab combined with standard chemotherapy can significantly improve the rate of pathological complete response pCR compared with standard chemotherapy
Detailed Description:
This study is a prospective open-label multi-center phase III study Patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma including oral cavity cancer oropharyngeal cancer hypopharyngeal cancer and laryngeal cancer who met the inclusion criteria were randomized in a 11 ratio and given 2 cycles of pembrolizumab 200 mg d1 chemotherapy see the table below for detailed chemotherapy regimens experimental group and 2 cycles of chemotherapy control group and were divided according to the patients condition layer If the imaging evaluation is CR after neoadjuvant treatment radiotherapy 60-70Gy chemotherapy investigators choice will be given as adjuvant treatment if the imaging evaluation is PR or SD surgery within 2 weeks will be performed and then standard treatment will be given treat If the imaging evaluation is PD standard treatment will be given Enrolled patients must closely monitor the adverse reactions of chemotherapy and record the time grade treatment measures outcomes etc All patients were reviewed every 3 months for 1 year after 1 year they were reviewed every 6 months for 3 years patient recurrence and survival data were recorded
The investigators speculate that compared with the traditional induction chemotherapy regimen the induction chemotherapy regimen of pembrolizumab combined with chemotherapy may be safer and more effective and easier for clinical application At present there are no research reports on the induction chemotherapy of pembrolizumab combined with cisplatin and nab-paclitaxel for patients with locally advanced operable head and neck squamous cell carcinoma We intend to conduct a randomized controlled study on the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in Chinese patients with operable head and neck squamous cell carcinoma and provide a basis for the neoadjuvant therapy of pembrolizumab combined with chemotherapy
The investigators speculate that compared with the traditional induction chemotherapy regimen the induction chemotherapy regimen of pembrolizumab combined with chemotherapy may be safer and more effective and easier for clinical application At present there are no research reports on the induction chemotherapy of pembrolizumab combined with cisplatin and nab-paclitaxel for patients with locally advanced operable head and neck squamous cell carcinoma We intend to conduct a randomized controlled study on the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in Chinese patients with operable head and neck squamous cell carcinoma and provide a basis for the neoadjuvant therapy of pembrolizumab combined with chemotherapy
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