Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648525
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Adebrelimab Combined with Irinotecan Liposomes 5-FU CF Lenvatinib As First-line Treatment for Advanced ICC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adebrelimab Combined with Irinotecan Liposomes 5-fluorouracil Calcium Folinate Lenvatinib As First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma a Prospective Clinical Study
Status:
NOT_YET_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:
This is a multicenter open label randomized two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes 5-fluorouracil calcium folinate lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma ICC
Detailed Description:
This study plans to recruit 68 patients with unresectable ICC who have not received prior systematic treatment The patients will be randomly divided into two groups Group A patients will receive adebrelimabirinotecan liposomes5-fluorouracilcalcium folinatelenvatinib Group B patients will receive treatment with adebrelimabirinotecan liposomes5-fluorouracilcalcium folinate The combination of irinotecan liposomes5-fluorouracilcalcium folinate will be used 9 times Q2W and adebrelimab lenvatinib will be used until disease progression or medication for 2 years
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