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Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma

ConditionExtrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAichi Medical University

About this trial

This international, multicenter, open-label randomized controlled trial evaluates whether repeated endobiliary radiofrequency ablation (EB-RFA) improves overall survival in patients with unresectable extrahepatic cholangiocarcinoma undergoing first-line systemic therapy with durvalumab plus gemcitabine and cisplatin (GCD). Eligible patients will be randomized 1:1 to EB-RFA with plastic stent placement or standard plastic stenting alone. A scheduled second endoscopic session will be performed at 3 months in both groups (repeat EB-RFA only in the EB-RFA arm). The primary endpoint is overall survival. Secondary endpoints include time to recurrent biliary obstruction, progression-free survival, adverse events, and technical/clinical success.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endobiliary Radiofrequency Ablation (EB-RFA)

    Device

    Endobiliary RFA performed using the ELRA® catheter (STARmed) with VIVA combo® generator. Recommended settings: 7-10 W, temperature control 80 °C, 120 seconds per application. Applied along the full stricture length. Repeat procedure at Month 3 (window 2-4 months). Additional sessions every ≥2 months permitted if imaging suggests ablatable residual lesion.

  • Plastic Biliary Stent

    Device

    Placement of 7Fr or 8.5Fr plastic biliary stent from hepatic side of the stenosis to the duodenum. Bilateral preferred for hilar strictures; unilateral acceptable based on drainage.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Endobiliary Radiofrequency Ablation + Plastic Stent + Durvalumab/Gemcitabine/CisplatinExperimental treatment 2 interventions
Group B: Plastic Stenting + Durvalumab/Gemcitabine/CisplatinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause. Participants still alive at the last confirmed contact will be censored at that date.

Time frame
From randomization until death from any cause (up to 36 months after last enrollment)

Secondary outcomes

1

Time to Recurrent Biliary Obstruction (TRBO)

TRBO is defined as the time from stent placement to recurrent biliary obstruction (RBO).

Time frame
From stent placement to RBO or censoring (up to 36 months)
2

Progression-Free Survival (PFS)

Progression-free survival is defined per RECIST v1.1 based on imaging performed every 2-4 months.

Time frame
From randomization to radiologic progression or death (up to 36 months)
3

Non-RBO Survival

Time alive without recurrent biliary obstruction.

Time frame
Up to 36 months
4

Survival Free From Late Biliary-Procedure-Related Adverse Events

Late adverse events are defined as events occurring ≥15 days after the procedure (Tokyo Criteria 2024).

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aichi Medical University

Lead sponsor

Source ClinicalTrials.gov
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