Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014372
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-08-23
Brief Title:
Envafolimab Monotherapy or Envafolimab CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Prospective Single-center Multi-cohort Study of Envolimab Monotherapy or Envafolimab in Combination With CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
Status:
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:
There exists substantial evidence suggesting that patients diagnosed with MSI-HdMMR colorectal cancer can derive benefits from immunotherapy in the management of advanced colorectal cancer In cases of locally advanced colorectal cancer exhibiting microsatellite instability dMMRMSI-H patients exhibit low responsiveness to neoadjuvant chemotherapy resulting in minimal rates of complete tumor remission and downstaging Nevertheless initial exploratory studies characterized by modest sample sizes reveal a favorable therapeutic effect of neoadjuvant immunotherapy in this particular patient population Envafolimab monoclonal antibody the first PD-L1 antibody developed and manufactured in China possesses noteworthy practical and societal value in the context of exploratory clinical research on neoadjuvant immunotherapy for locally advanced MSI-HdMMR colorectal cancer patients The objective of this study is to evaluate the safety and efficacy of envafolimab monoclonal antibody PD-L1 as neoadjuvant therapy for locally advanced MSI-HdMMR colorectal cancer through a prospective multi-cohort phase II clinical trial Additionally this study aims to investigate the effectiveness and safety of envafolimab monoclonal antibody in combination with CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR colorectal cancer
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?:
False
Is an FDA AA801 Violation?:
None