RecruitingPhase 2NCT06440993

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


Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

42 participants

Start Date

Aug 23, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of durvalumab (an immunotherapy drug) and a procedure called intraductal radiofrequency ablation (ID-RFA) — which uses heat energy delivered inside the bile duct to destroy tumor tissue — for people with a bile duct cancer called extrahepatic cholangiocarcinoma. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with extrahepatic cholangiocarcinoma (cancer of the bile ducts outside the liver) - Your cancer is not surgically removable - You are well enough to undergo the procedures and follow-up visits **You may NOT be eligible if...** - You have significant heart, liver, or kidney problems - You have active autoimmune disease or are on immunosuppressive medications - You have previously received certain cancer treatments that are not allowed in this study - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

Gemcitabine, 1,000 mg/m2 IV

DRUGCisplatin

Cisplatin, 25 mg/m2 IV

DRUGDurvalumab

Durvalumab, 1,500 mg IV

PROCEDUREID-RFA

endoscopic intraductal RFA


Locations(10)

Uniklinik RWTH Aachen

Aachen, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Köln

Cologne, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Krankenhaus Nordwest

Frankfurt, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

UKSH Campus Lübeck

Lübeck, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Germany

Universitätsklinik Münster

Münster, Germany

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NCT06440993


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