Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455254
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-07
Brief Title:
Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM
Sponsor:
Jin-hong Chen
Organization:
Fudan University
Study Overview
Official Title:
A Single-arm Multicenter Phase II Study to Evaluate the Efficacy and Safety of CandonilimabAK104 Combined With Regorafenib For the Third-line Treatment of MSS Colorectal Liver Metastasis
Status:
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:
This study is a single-arm open-label multicenter clinical study to evaluate the efficacy and safety of Candonilimab AK104 combined with Regorafenib for the treatment of MSS colorectal liver metastasis Candonilimab AK104 is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4
Detailed Description:
This is a single-arm open-label multicenter clinical study to evaluate the efficacy and safety of Candonilimab AK104 combined with Regorafenib for the treatment of MSS colorectal liver metastasis The purpose of the study is to observe and evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib in patients with CRLM who had failed the previous second-line standard regimen and to explore biomarkers related to efficacy
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