Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440993
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Durvalumab Intraductal Radiofrequency Ablation ID-RFA in Extrahepatic Cholangiocarcinoma
Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Organization:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Overview
Official Title:
The CLEAN-DUCT TRITICC-3 Trial - Phase IIa Prospective Single Arm Open Label Non-randomized Multi-center Pilot Study of Durvalumab MEDI4736 Intraductal Radiofrequency Ablation ID-RFA in Extrahepatic Cholangiocarcinoma
Status:
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:
None
Brief Summary:
The present clinical trial is a prospective investigator-initiated single-arm open-label multicenter phase II trial Patients with unresectable perihilar andor ductal CCA with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team MDT who already resolved cholestasis due to RFA Stent will be enrolled
We hypothesize that in patients with extrahepatic cholangiocarcinoma the use of a combination radiofrequency ablation followed by systemic treatment with chemotherapy plus durvalumab might further increase the anti-tumor activity
We hypothesize that in patients with extrahepatic cholangiocarcinoma the use of a combination radiofrequency ablation followed by systemic treatment with chemotherapy plus durvalumab might further increase the anti-tumor activity
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 |
|---|---|---|---|
| 2023-509165-21-00 | CTIS | None | None |
| ESR-23-22156 | OTHER_GRANT | None | None |
| IKF-t070 | OTHER | IKF Trial ID | None |