Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-28
Brief Title:
Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSSpMMR Colorectal Cancer Patients
Sponsor:
Chipscreen Biosciences Ltd
Organization:
Chipscreen Biosciences Ltd
Study Overview
Official Title:
A Randomised Open-label Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSSpMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
A randomised open-label multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSSpMMR colorectal cancer patients
Detailed Description:
This is a randomised open-label multicenter phase III study evaluating the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSSpMMR colorectal cancer patients 430 patients will be randomised 11 to receive tucidinostat in combination with sintilimab and bevacizumab experimental arm or fruquintinib monotherapy control arm
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