Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
Survival Impact of Repeated Endobiliary Radiofrequency Ablation in Patients Undergoing Durvalumab Plus Gemcitabine and Cisplatin for Extrahepatic Cholangiocarcinoma: An International Multicenter Randomized Controlled Trial (BRAVE Trial)
Aichi Medical University
120 participants
Nov 20, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- Histologically or cytologically confirmed extrahepatic cholangiocarcinoma (eCCA).
- Unresectable disease (unresectable due to tumor/patient factors, or patient refusal of surgery).
- Biliary obstruction requiring drainage, demonstrated by abnormal cholestatic liver tests, elevated bilirubin, radiologic evidence, or existing biliary drainage.
- Planned initiation of first-line systemic therapy with durvalumab + gemcitabine + cisplatin (GCD).
- Age ≥18 years.
- Able to provide written informed consent.
Exclusion Criteria9
- Prior radiotherapy or systemic therapy for the current eCCA.
- Presence of a self-expanding metal stent that cannot be endoscopically removed.
- Surgically altered anatomy except for Billroth-I; prior biliary reconstruction.
- History of chronic cholangitis (e.g., primary sclerosing cholangitis, IgG4-related cholangitis).
- Expected survival \<3 months.
- Inability to insert an oral endoscope or reach the papilla.
- Contraindication to endobiliary RFA.
- Pregnancy or possible pregnancy.
- Any condition judged unsuitable by the investigator.
Interventions
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.
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.
Locations(8)
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NCT07235007