Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301386
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Brief Title:
Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
The Combination of Everolimus and PD-1 in the Treatment of Locally Advanced and Advanced Colorectal Cancer That Cannot be R0 Resected
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected The main question is to explore the survival time safety and tolerability of the treatment At the same time the correlation between biomarkers including PD-L1 expression tumor mutation load lymphocyte subpopulation cytokines TCR intestinal microbes and others and the efficacy and drug resistance mechanism will be analyzed so as to provide reference for the subsequent guidance of the screening of benefit groups
Detailed Description:
Everolimus is an oral protein kinase inhibitor of the mTOR mammalian target of rapamycin serinethreonine kinase signal transduction pathway Studies have shown that immunotherapy combined with protein kinase inhibitor has initial efficacy in the treatment of colorectal cancer Therefore the objective of this study is to evaluate the efficacy and safety of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected
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