Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05327582
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2022-04-07
Brief Title:
An Open-label Phase III Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
A Phase III Open-label One-arm Single-center Study to Evaluate the Safety and Efficacy of the PLENA Regimen in Subjects With Unresectable Pancreatic Cancer or Biliary Tract Cancer
Status:
UNKNOWN
Status Verified Date:
2022-04
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:
Immunotherapy of cancer based on PD-1PD-L1 blockade has prompted a revolution in cancer clinical management albeit as yet immunotherapy-based treatment approaches in pancreatic cancer and biliary tract cancer BTC remain to have proven value highlights the urgency for designing novel therapeutic strategies to combat these deadly diseases The immunomodulatory effect of lenvatinib Lenvatinib is an oral multi-kinase inhibitor on tumor microenvironments may contribute to antitumor activity of immune checkpoint blockade This one-arm phase III study is designed to assess the safety and efficacy of the combined regimen of Durvalumab anti-PD-L1 antibody Lenvatinib and Paclitaxel albumin nab-paclitaxel
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