drugset / Trial / NCT06440993

Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma

NCT06440993 ↗

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

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications