Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 12:03 PM
Study NCT ID:
NCT05335460
Status:
UNKNOWN
Last Update Posted:
2022-04-19
First Post:
2022-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer
Sponsor:
Fujian Cancer Hospital
Organization:
Study Overview
Official Title:
Envafolimab Combined With XELOX in Neoadjuvant Therapy for Locally Advanced Colon Cancer，A Prospective, Single Arm, Single Center ǁ Phase Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
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 objective is to investigate the efficacy and safety of Envafolimab combined with XELOX in neoadjuvant therapy for locally advanced colon cancer
Detailed Description:
According to the 2019 NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment.
This study is a single-center, single-arm phase II study, patients received neoadjuvant therapy with Envafolimab combined with XELOX regimen, with one treatment cycle every 3 weeks and after two cycles accept surgery. To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment.
This study is a single-center, single-arm phase II study, patients received neoadjuvant therapy with Envafolimab combined with XELOX regimen, with one treatment cycle every 3 weeks and after two cycles accept surgery. To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment.
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?: