Actively Recruiting
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-12-01
42
Participants Needed
10
Research Sites
188 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
U
Universitätsklinikum Düsseldorf, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has given written informed consent.
- Patient is 18 years of age or older at time of consent.
- Patient agrees and is able to follow the study protocol including treatments and scheduled visits.
- Patient has histologically or cytologically confirmed adenocarcinoma of pancreatobiliary type.
- Patient has unresectable perihilar and/or ductal cholangiocarcinoma requiring bile duct stenting and palliative systemic therapy, with resolved cholestasis due to RFA plus stent.
- Patient tolerated prior RFA and is eligible for repeat RFA during the study.
- Patient is eligible for palliative systemic therapy based on clinical and lab results except hyperbilirubinemia.
- Patient has an ECOG performance status of 0 or 1.
- Patient has a life expectancy of at least 12 weeks.
- Patient weighs more than 30 kg.
- Adequate blood count, liver enzyme, and kidney function as specified.
- Patients of childbearing potential agree to use effective contraception or abstinence during treatment and specified follow-up periods.
You will not qualify if you...
- Patient received previous or concurrent endobiliary treatments other than RFA (e.g., photodynamic therapy or brachytherapy).
- Patient previously treated with PD-1, PD-L1 inhibitors (including durvalumab), CTLA4 inhibitors, or platinum, fluoropyrimidine, or gemcitabine chemotherapy.
- Patient is receiving concurrent chemotherapy, investigational products, or hormonal therapy for cancer treatment (except hormonal therapy for non-cancer conditions).
- Known hypersensitivity to durvalumab, gemcitabine, cisplatin, or related antibodies.
- History of primary immunodeficiency.
- Stage B or worse cirrhosis or cirrhosis with significant complications.
- Unresolved grade 2 or higher toxicity from prior cancer treatments, except specified exceptions.
- Prior allogeneic bone marrow or solid organ transplantation.
- Active or history of autoimmune or inflammatory disorders, with specified exceptions.
- Uncontrolled illnesses including active infection, heart failure, uncontrolled hypertension, unstable angina, arrhythmia, lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance or consent.
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Trial Site Locations
Total: 10 locations
1
Uniklinik RWTH Aachen
Aachen, Germany
Actively Recruiting
2
Universitätsklinikum Bonn
Bonn, Germany
Actively Recruiting
3
Universitätsklinikum Köln
Cologne, Germany
Actively Recruiting
4
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Actively Recruiting
5
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Actively Recruiting
6
Universitätsmedizin Göttingen
Göttingen, Germany
Actively Recruiting
7
Medizinische Hochschule Hannover
Hanover, Germany
Actively Recruiting
8
UKSH Campus Lübeck
Lübeck, Germany
Actively Recruiting
9
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany
Actively Recruiting
10
Universitätsklinik Münster
Münster, Germany
Not Yet Recruiting
Research Team
C
Christoph Roderburg, Prof. Dr.
CONTACT
J
Johanna Riedel, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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