Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06109779
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-10-26
Brief Title:
Rilvegostomig Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection ARTEMIDE-Biliary01
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Multicenter Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent ARTEMIDE-Biliary01
Status:
RECRUITING
Status Verified Date:
2024-09
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:
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigators choice of chemotherapy in participants with BTC after surgical resection with curative intent
Detailed Description:
This is a Phase III randomized double-blind placebo-controlled multicenter global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigators choice of chemotherapy capecitabine S-1tegafur gimeracil oteracil or gemcitabinecisplatin as adjuvant treatment in participants with BTC after resection with curative intent This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506054-20-00 | OTHER | EU Clinical Trial Number | None |