Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03478488
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2018-03-21
Brief Title:
Programmed Death Ligand PD-L1 Combined With Chemotherapy for Patients With BTC
Sponsor:
3D Medicines Sichuan Co Ltd
Organization:
3D Medicines
Study Overview
Official Title:
Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer a Randomised Open-label Parallel-group Multicenter Phase III Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
KN035-BTC
Brief Summary:
This is a randomized open-label parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care SOC Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer
The primary hypothesis of this study is that participants will have a longer overall Survival OS when treated with combined therapy than SOC
The primary hypothesis of this study is that participants will have a longer overall Survival OS when treated with combined therapy than SOC
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