Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05291052
Status:
UNKNOWN
Last Update Posted:
2022-03-22
First Post:
2022-03-14
Brief Title:
Tisleizumab Combined With Lenvatinib and XELOX Regimen Oxaliplatin Combined With Capecitabine in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Single-arm Open-label Clinical Study of Combined Therapy of Tisleizumab Lenvatinib and XELOX Regimen Oxaliplatin Combined With Capecitabine in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
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-center single-arm open-label clinical study All patients with advanced and unresectable biliary tract tumors will be treated with the combination of tisleizumab lenvatinib and XELOX regimen oxaliplatin plus capecitabine until disease progression unacceptable toxicity death or the patient meets any other discontinuation criteria described in the protocol whichever occurs first Subjects can receive up to 8 cycles of the XELOX regimen For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years Patients will be closely monitored for safety and tolerability throughout the study
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?:
None
Is an FDA AA801 Violation?:
None