Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356688
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Sponsor:
Sun Jing
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell CarcinomaA Single Arm Single Center Prospective Clinical Trial POINTS Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1CTLA-4 bispecific antibody cadonilimab in combination with platinum-containing chemotherapy paclitaxel polymer micelles combined with cisplatin Includes pathologic complete remission rates pCR rates after 2-4 cycles of cadonilimab combination chemotherapy The objective remission rate ORR major pathologic remission rate MPR R0 resection rate and 2-year overall survival OS and progression-free survival OS rates and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with cadonilimab combined with chemotherapy
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