Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230471
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-10
Brief Title:
Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Phase II Multicenter Randomized Study of Pembrolizumab With or Without Chemotherapy or Lenvatinib in First-Line Treatment of Advanced Biliary Tract Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Explore the impact of the first-line application of Pembrolizumab with or without Lenvatinib or chemotherapy on the survival disease progression and drug safety of patients with advanced biliary tract cancers
Detailed Description:
This trial is a three-arm randomized multi-center clinical study Eligible subjects who meet the study criteria will be screened and randomized in a 111 ratio to receive treatment with intravenous infusion of Pembrolizumab with or without chemotherapy and oral lenvatinib The investigators will closely follow up and assess the efficacy and safety of the combined treatment evaluate the progression-free survival of the subjects until progression occurs and observe their overall survival as a secondary outcome
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