Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178445
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-12-11
Brief Title:
Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer
Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Organization:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Overview
Official Title:
Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
TRAP-BTC
Brief Summary:
This is a multicenter single arm prospective open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy gemcitabinecisplatin trastuzumab pembrolizumab as first-line treatment for cholangiocarcinoma and gallbladder cancer patients
Patients suffering from previously untreated HER2 human epidermal growth factor receptor 2 positive unresectable cholangiocarcinoma and gallbladder cancer will be included in the study and are scheduled to receive triplet regimen consisting of a combination of pembrolizumab trastuzumab and gemcitabinecisplatin GemCis
Patients suffering from previously untreated HER2 human epidermal growth factor receptor 2 positive unresectable cholangiocarcinoma and gallbladder cancer will be included in the study and are scheduled to receive triplet regimen consisting of a combination of pembrolizumab trastuzumab and gemcitabinecisplatin GemCis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU CT number | OTHER | European Union | None |