Endoscopic radiofrequency ablation for unresectable bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares two groups: standard care with systemic therapy and stenting, versus standard care plus intraductal radiofrequency ablation. It aims to see if ablation reduces complications such as stent blockage, delays in chemotherapy, or infections, and whether it is safe in this setting. Participants have unresectable perihilar or ductal cholangiocarcinoma and meet specified health criteria. The study will enroll adults who have not had prior biliary RFA and have acceptable organ function per the local team. Outcomes of interest include safety and potential reductions in treatment-related complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT)
2. Written informed consent
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Age ≥18 years
5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT
6. No prior radiofrequency ablation (RFA) for CCA
7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months)
8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent

Where it's running

• Charite
  Berlin, Germany Recruiting
• University Medical Center
  Bonn, Germany Recruiting
• Clinic Chemnitz
  Chemnitz, Germany Recruiting
• University Clinic
  Essen, Germany Recruiting
• University Medical Center Hamburg-Eppendorf
  Hamburg, Germany Recruiting
• Medical School Hannover
  Hanover, Germany Recruiting

Study contacts

• Principal investigator: Johann von Felden, MD — Universitätsklinikum Hamburg-Eppendorf
• Study coordinator: Project Manager
• Email: acticca2@aio-studien-ggmbh.de
• Phone: + 49 30 8145344 37

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.