Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513221
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy Bevacizumab Combined With Adebrelimab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multi-arm Phase II Clinical Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy Bevacizumab Combined With Adebrelimab Under the Guidance of Transcriptome Profiling
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective multi-arm phase II clinical trial that uses transcriptome profiling to guide the evaluation of the efficacy of multiple lines of standard chemotherapy and bevacizumab combined with adebrelimab in patients with MSS-type metastatic colorectal cancer aiming to expand the immunotherapy cohort while accurately narrowing the population of MSS-type colorectal cancer that benefits from immunity This study includes a screening period a treatment period and a follow-up period
Detailed Description:
This study plans to include a total of 100 first-line second-line and third-line MCRIH MSS Colorectal Cancer Immuno-Hot participants First-line and second-line participants who pass the screening period will receive standard chemotherapy XELOXmXELIRI conventional dose combined with Bevacizumab 75mgkg q3w and Adebrelimab 1200mg q3w third-line subjects will receive Fruquintinib 4mg po d1d14 q3w combined with Adebrelimab 1200mg q3w Participants will receive imaging examinations during the treatment period to evaluate efficacy and progression In addition any adverse reactions at any time will be recoded to evaluate safety The EDC system will be used to collect statistics on participants examination data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None