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Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
Sponsor: Aichi Medical University
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-11-20
Completion Date
2030-12-31
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
Endobiliary Radiofrequency Ablation (EB-RFA)
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
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)
Aichi Medical University
Aichi, Japan
Nagoya City University Hospital
Aichi, Japan
Nagoya City University Midori Municipal Hospital
Aichi, Japan
Gifu University Hospital
Gifu, Japan
Pusan National University Hospital
Busan, South Korea
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea