Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152978
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2022-11-01
Brief Title:
A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Prospective Open-label Randomized Phase II Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy Versus Chemotherapy in Perioperative Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma ECTOP-2006
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma
Detailed Description:
This study was designed as an open-label randomized controlled phase II trial Subjects will be systematically randomized at a ratio of 11 and will be assigned to either the experimental group sintilimab combined with chemotherapy group or the control group chemotherapy alone group They will receive 2-3 cycles of neoadjuvant therapy followed by radical esophagectomy and lymph node dissection and adjuvant therapy determined by investigators The primary endpoint is 1-year Event-free survival EFS rate
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