Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341296
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-26
Brief Title:
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Phase II Study of Irinotecan Liposomes Combined With 5-FULV Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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:
To evaluate the objective response rate disease control rate progression-free survival overall survival surgical conversion rate and safety of irinotecan liposome combined with 5-FULV bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients
Detailed Description:
This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer Patients will receive liposomal injections of irinotecan 70mgm2 d1 bevacizumab 5mgkg d1 LV 400mgm2 d1 5-FU 400mgm2 then 2400mgm2 continuous intravenous infusion for 46-48h d1-2 86 eligible patients will be enrolled
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