Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924880
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-06-01
Brief Title:
A Phase 3b Open-label Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers BTC
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase IIIb Single Arm Open-label Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as First Line Treatment for Chinese Patients With Unresectable Biliary Tract Cancers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
TopDouble
Brief Summary:
This is a Phase IIIb open-label single arm multicentre study to assess the safety and efficacy of durvalumab in combination with investigators choice of 3 different gemcitabine-based chemotherapy regimens in participants with aBTC with a WHOECOG PS of 0 to 2 at enrolment
Detailed Description:
The primary objective of the study is to assess the safety of durvalumab combined with gemcitabine-based chemotherapy for participants with advanced BTC who have not previously received systemic therapy for advanced or metastatic BTC with WHOECOG PS of 0 to 2
Eligible participants will received durvalumab in combination with gemcitabine-based chemotherapyGemcitabineOxalipatin GemcitabineS1 GemcitabineCisplatin by investigators choice
Eligible participants will received durvalumab in combination with gemcitabine-based chemotherapyGemcitabineOxalipatin GemcitabineS1 GemcitabineCisplatin by investigators choice
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