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Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06440993•Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient\* has given written informed consent.
•2. Patient is ≥ 18 years of age at time of signing the written informed consent.
•3. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
•4. Patient has been diagnosed with histologically or cytologically confirmed
•1. histologically or cytologically confirmed cholangiocarcinoma as adenocarcinoma of pancreatobiliary type
•2. unresectable perihilar and/or ductal cholangiocarcinoma with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team (MDT) and already resolved cholestasis due to RFA + stent
•5. Patient tolerated RFA prior to inclusion and is eligible for repeat RFA during the study (does not have any contraindications) as determined by investigator.
•6. Patient is eligible for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT
•7. Patient has a ECOG ≤ 1.
•8. Patient has life expectancy of ≥ 12 weeks
+21 more criteria

Exclusion Criteria

•1. Patient received previous or simultaneous endobiliary treatment other than RFA (e.g. PDT or brachytherapy)
•2. Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor or classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine-based regimens.
•3. Patient receives any concurrent chemotherapy, investigational product or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replace therapy) is acceptable.
•4. Patient has known hypersensitivity to any component of the durvalumab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to gemcitabine or cisplatin.
•5. Patient has history of primary immunodeficiency
•6. Patient has stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.

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

Key Dates

Start Date

August 23, 2024

Primary Completion Date

January 1, 2027

Completion Date

April 1, 2028

Last Updated

December 1, 2025

Enrollment

ESTIMATED participants

Conditions

Extrahepatic CholangiocarcinomaUnresectable Perihilar or Ductal CCA

Interventions

Gemcitabine

DRUG

Cisplatin

DRUG

Durvalumab

DRUG

ID-RFA

PROCEDURE

Contacts

Christoph Roderburg, Prof. Dr.

CONTACT

+49 211 8108030 christoph.roderburg@med.uni-duesseldorf.de

Johanna Riedel, Dr.

CONTACT

+49 69 5899 787 clean-duct@ikf-khnw.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma