Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194695
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-22
Brief Title:
DEB-TACE Lenvatinib and Anti-PDL1 Antibody as Conversion Therapy for Intrahepatic Cholangiocarcinoma
Sponsor:
Ze-yang Ding MD
Organization:
Tongji Hospital
Study Overview
Official Title:
Combination of Transcatheter Arterial Chemoembolization With Drug-eluting Beads Lenvatinib and Anti-PDL1 Antibody for Downstaging Intrahepatic Cholangiocarcinoma for Radical Surgical Treatment
Status:
RECRUITING
Status Verified Date:
2024-01
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:
CCGLC-009
Brief Summary:
The aim of this study is to the efficacy prognosis adverse effects and factors for predicting therapeutic effects and clinical prognosis of combined therapy of Drug-eluting Beads-transarterial chemoembolization DEB-TACE lenvatinib and anti-PD-1 PD-L1 antibody for patients with advanced intrahepatic cholangiocarcinoma who were initially unsuitable for the radical therapy including resection transplantation or ablation
Detailed Description:
The multicenter non-random open and prospective real-world cohort study is conducted at 4 research centers including 3 centers Hankou Sino-French New District and Optical Valley of Tongji hospital Wuhan China and one in the second affiliated hospital of Fujian Medical University Quanzhou China It is estimated that 100 patients with advanced intrahepatic cholangiocarcinoma will be enrolled in these 4 research centers And it is planned to complete the enrollment within 2 year and it is expected that all enrolled subjects will reach the observation end point in 3 years Radiological assessments are performed every two cycles over the course of treatment then every 3 months within the first two years following the completion of treatment and every 6 months thereafter until PD were recorded All subjects are followed until death or lost to follow up
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