Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304350
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-02-21
Brief Title:
Pembrolizumab Combined With Preoperative Chemotherapy Albumin PaclitaxelCarboplatin Neoadjuvant Therapy for Resectable Locally Advanced Stage IIIII Esophageal Squamous Cell Carcinoma
Sponsor:
Tongji University
Organization:
Tongji University
Study Overview
Official Title:
A Single Arm Single Center Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy Albumin PaclitaxelCarboplatin Neoadjuvant Therapy for Resectable Locally Advanced Stage IIIII Esophageal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This study is a prospective single center open label single arm clinical study Select resectable locally advanced cT3-4aN0M0 cT1-3N1-2M0 cIIIII stage esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion receive pembrolizumab combined with platinum containing dual drug albumin paclitaxelcarboplatin treatment for 2 courses and undergo surgery After surgery continue pembrolizumab immunotherapy Using pCR as the main endpoint of the study
Detailed Description:
This study is a prospective single center open label single arm Phase II clinical study Patients with locally resectable advanced esophageal squamous cell carcinoma were selected for inclusion in the study who received a 2-course neoadjuvant treatment with pembrolizumab combined with platinum containing dual drugs After evaluation surgery was performed The efficacy and safety of pembrolizumab combined with chemotherapy neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma were observed with pCR and MPR as the main research endpoints
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