Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05781074
Status:
RECRUITING
Last Update Posted:
2023-03-24
First Post:
2023-02-07
Brief Title:
Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer CASTLE-08
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase II Study of Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer
Status:
RECRUITING
Status Verified Date:
2023-03
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:
CASTLE-08
Brief Summary:
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with Immune Checkpoint Inhibitor previously treated advanced biliary tract cancer BTC
Detailed Description:
Recent studies have suggested that local destruction of tumor tissue by cryoablation induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens While pd-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many type of human cancers Therefore the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with Immune Checkpoint Inhibitor previously treated advanced BTC
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