Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603376
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Irinotecan Hydrochloride Liposome Injection Ⅱ Combined with Fluorouracil Folinic Acid Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Multicenter Controlled Study of Irinotecan Hydrochloride Liposome Injection Ⅱ Combined with Fluorouracil Folinic Acid Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Based on the upstream signaling features of BRAFV600E and the bypass feedback mechanisms considering the pro-apoptotic effects of chemotherapy and the synergistic effects of targeted therapy previous IMPROVEMENT trial creatively explored a balanced chemotherapy-targeted combination approach FOLFIRI Vemurafenib Cetuximab in advanced colorectal cancer patients with BRAF V600E mutaiton using a signle-arm study design demonstrating significant therapeutic efficacy in these patietns To further validate the effectiveness and safety of this regimen and to solidify its clinical value it is crucial to conduct a randomized controlled trial Investigators plan to use the current standard regimen as a control to compare this strategy FOLFIRI Vemurafenib Cetuximab on a large cohort of patients with BRAFV600E-mutant advanced colorectal cancer in the first-line setting focusing on its efficacy and safety
Detailed Description:
None
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