Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05410197
Status:
RECRUITING
Last Update Posted:
2022-10-12
First Post:
2022-06-04
Brief Title:
Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line TreatmentENLIGHTEN
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Envofolimab and Lenvatinib in Combination With Gemcitabine Plus Cisplatin for Patients With Advanced Biliary Tract Cancer as First-Line Treatment A Single-arm Open-label Phase II Study
Status:
RECRUITING
Status Verified Date:
2022-10
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 is a phase 2 single-arm open label study The purpose is to investigate both the efficacy and safety of Envofolimab and Lenvatinib in combination with Gemcitabine plus Cisplatin for treatment of advanced biliary tract cancer as first-line treatment
Detailed Description:
The trial will recruit 43 patients At the first step 10 patients will be recruited Only when at least 4 patients achieve objective response will the trial enter the second step and continue to recruit other patients After being enrolled all patients giving written informed consent will receive treatment until progression of disease unacceptable toxicity or death The tumor response evaluation will be conducted on a regular basis until progression of disease Long-term survival follow up will be conducted as well
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