Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
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
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
42 participants
Aug 23, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
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Interventions
Gemcitabine, 1,000 mg/m2 IV
Cisplatin, 25 mg/m2 IV
Durvalumab, 1,500 mg IV
endoscopic intraductal RFA
Locations(10)
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NCT06440993