Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic … (NCT06274879) | Clinical Trial Compass
RecruitingPhase 2
Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer
Switzerland36 participantsStarted 2026-05-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female ≥18 years old.
. Histologically or cytologically confirmed diagnosis of previously untreated and unresectable\*, locally advanced and/or metastatic extrahepatic biliary tract cholangiocarcinoma with obstructive jaundice (increased serum level of total bilirubin).
. ECOG performance status 0 to 2.
. Adequate bone marrow function: Neutrophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L.
. Adequate renal function in case of cisplatin administration: Estimated Glomerular Filtration Rate (eGFR) ≥60mL/min/1.73m2.
. Willing and able to provide written informed consent.
. Planned initiation of any standard-of-care systemic anti-proliferative therapy against ETB.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial focused on safety — what does that mean for how much we already know about the risks of this intraductal radiofrequency ablation procedure in bile duct cancer, and how does that uncertainty factor into whether it might be right for me?
2The trial is specifically measuring serious grade 3 or 4 side effects that could force a pause or stop of systemic anti-tumor therapy or immunotherapy — how likely are those kinds of complications based on what's been seen so far, and what would happen to my overall treatment plan if I experienced one?
3Since this trial is for unresectable extrahepatic biliary tract cancer, can you explain how adding intraductal radiofrequency ablation to my current or planned systemic treatment compares to continuing with standard therapy alone, and what the realistic goals of each approach would be for my situation?
4The trial involves a procedure directly inside the bile duct — what are the logistical demands, like how often I'd need to come in, how invasive the procedure is, and what recovery looks like, and is that realistic given my current health and daily life?
5Are there standard-of-care treatments or other clinical trials I should consider before or instead of this one, given that this study is still in the process of establishing safety rather than confirming benefit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Any grade 3 or 4 adverse events (AE) leading to systemic anti-tumor therapy with or without ICI discontinuation up to six months after randomization.
. Solely intrahepatic cholangiocarcinoma or mixed type liver tumors (cholangiocarcinoma with hepatocellular differentiation parts).
. Multiple hepatic metastases with significant blockage of one or more liver segments and/or less than 50% of liver parenchyma potentially drainable on pre-intervention imaging.
. In case of immune-checkpoint-inhibitor (ICI) administration, any autoimmune diseases including inflammatory disorders such as Crohn's disease, ulcerative colitis, Wegener granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease.
. Use of immunosuppressive medication within 3 weeks prior to ICI administration.
. Prior Self-Expandable Metal Stent (SEMS) placement in the biliary tree.
. Biliary obstruction of non-tumoral etiology.
. Platelets \<100 x 109/L or International Normalized Ratio (INR) \>1.5.