drugset / Trial / NCT06440993
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
Phase 2
Recruiting
42 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
AstraZeneca · collabUniversitätsklinikum Düsseldorf, Germany · collabUniversitätsklinikum Köln · collab
NaSingle-groupOpen-labelTreatment
Summary
The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial. Patients with unresectable perihilar and/or 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.
Timeline
- Start
- 2024-08-23
- Primary completion
- 2027-01
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |