RecruitingPhase 2NCT06274879

Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer

Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer (EBTC) Undergoing Systemic Anti-tumor Therapy: a Phase II, Multi-center, Randomized, and Controlled Study (Ablatio-bilica)


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

36 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). The main question it aims to answer is whether it is safe to combine systemic anti-tumor therapy with or without ICI with and bRFA. Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and systemic anti-tumor therapy, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined. Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biliary Radiofrequency Ablation, a procedure called Endoscopic Retrograde Cholangio-Pancreatography with stenting, and others for people with bile duct cancer. The study is currently recruiting participants at 4 locations.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGemcitabin, Cisplatin and Durvalumab

CICI (Gemcitabin d1 \& d8 Cisplatin d1 \& d8, Durvalumab d1) are administered repeating every 21 days for a total of 8 cycles.

PROCEDUREBiliary Radiofrequency Ablation

Biliary Radiofrequency Ablation is applied at baseline, 6 and 12 weeks

PROCEDUREEndoscopic Retrograde Cholangio-Pancreatography with stenting

ERCP with stenting are applied at baseline and as clinically indicated


Locations(4)

Inselspital Bern University Hospital

Bern, Switzerland

Hôpitaux Universitaires Genève

Geneva, Switzerland

Luzerner Kantonspital

Lucerne, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06274879


Related Trials