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

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT06274879
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Bile Duct Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabin, Cisplatin and Durvalumab — DRUG
    CICI (Gemcitabin d1 \& d8 Cisplatin d1 \& d8, Durvalumab d1) are administered repeating every 21 days for a total of 8 cycles.
  • Biliary Radiofrequency Ablation — PROCEDURE
    Biliary Radiofrequency Ablation is applied at baseline, 6 and 12 weeks
  • Endoscopic Retrograde Cholangio-Pancreatography with stenting — PROCEDURE
    ERCP with stenting are applied at baseline and as clinically indicated

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control arm
    Standard of care consisting of chemotherapy + durvalumab + endoscopic stenting
  • Experimental: Biliary radiofrequency ablation
    Standard of care consisting of chemotherapy + durvalumab + endoscopic stenting plus intraductal radiofrequency ablation (bRFA)

Primary Outcome Measure

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. [ Time Frame: 6 months ]

Central Contacts

Related Studies