Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335927
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-22
Brief Title:
HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Hepatic Arterial Infusion Chemotherapy Combined With Cadonilimab and Regorafenib as Second-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma a Single-arm Phase II Study
Status:
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:
This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma
The study plans to enroll approximately 45 participants All enrolled participants will receive continuous treatment HAIC-Gemox Gemcitabine 1000mgm2 on Day 1 Oxaliplatin 85mgm2 on Day 1 every 3 weeks Q3W for up to 6 treatment cycles Cadonilimab6mgkg D2 Q3W and Regorafenib 80mg QD Q3W until the investigator determines that there is no longer any clinical benefit based on comprehensive assessment including RECIST v11 imaging evaluation and clinical condition intolerable toxicity initiation of new anti-tumor therapy or meeting other criteria for treatment discontinuation whichever occurs first
The study plans to enroll approximately 45 participants All enrolled participants will receive continuous treatment HAIC-Gemox Gemcitabine 1000mgm2 on Day 1 Oxaliplatin 85mgm2 on Day 1 every 3 weeks Q3W for up to 6 treatment cycles Cadonilimab6mgkg D2 Q3W and Regorafenib 80mg QD Q3W until the investigator determines that there is no longer any clinical benefit based on comprehensive assessment including RECIST v11 imaging evaluation and clinical condition intolerable toxicity initiation of new anti-tumor therapy or meeting other criteria for treatment discontinuation whichever occurs first
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None