Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05877001
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-01-17
Brief Title:
The Safety and Efficacy of HAICTislelizumabRegorafenib in Patients With Colorectal Liver Metastases
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
An Open Label Single-center Study on the Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib in Patients With Advanced Treated Colorectal Liver Metastases
Status:
RECRUITING
Status Verified Date:
2022-12
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:
Tislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and with minimized Fcγ receptor binding on macrophages Regorafenib has been approved in mCRC by CFDA Hepatic arterial infusion chemotherapy has a high local control rate for liver metastases NCCN guidelines and several expert consensus recommend that regional hepatic arterial infusion chemotherapy can be considered as a rescue treatment for patients with colorectal cancer liver metastases who fail to receive first-line or second-line systemic chemotherapy which can significantly prolong the overall survival of patients
Detailed Description:
The investigators aimed to evaluated the safety and efficacy of HAIC combined with Tislelizumab and Regorafenib in patients with advanced treated colorectal liver metastases This study is a prospective open label single-center clinical study and the sample size is 20
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