Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06391905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS
Sponsor:
Guangdong Provincial People's Hospital
Organization:
Study Overview
Official Title:
PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS
Status:
NOT_YET_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:
The purpose of this study is to preliminarily observe the efficacy and safety of PCSK9 inhibitors in combination with standard advanced first-line regimens in the treatment of advanced colorectal cancer with pMMR/MSS.
Detailed Description:
The purpose of this study is to preliminarily observe the efficacy and safety of PCSK9 inhibitors in combination with standard advanced first-line regimens in the treatment of advanced colorectal cancer with pMMR/MSS. To evaluate progression-free survival (PFS) after PCSK9 inhibitor combination, overall survival (OS) after PCSK9 inhibitor combination, and to evaluate the safety and tolerability of PCSK9 inhibitor combination therapy based on NCI-CTCAE version 4.03, and to further explore efficacy predictive biomarkers based on changes in the expression of specific immune markers in blood and tissue specimens at baseline and after 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?:
False
Is an FDA AA801 Violation?: