RecruitingNot ApplicableNCT07235007

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)

Sponsor

Aichi Medical University

Enrollment

120 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Extrahepatic Cholangiocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a local heat treatment inside the bile duct (radiofrequency ablation) combined with a standard immunotherapy and chemotherapy regimen can improve outcomes for people with bile duct cancer (cholangiocarcinoma) that cannot be surgically removed. **You may be eligible if...** - You have been confirmed to have bile duct cancer (specifically the type outside the liver — extrahepatic cholangiocarcinoma) - Your cancer cannot be surgically removed - You are starting first-line treatment with durvalumab, gemcitabine, and cisplatin - You have a blockage in your bile duct that needs drainage - You are 18 or older **You may NOT be eligible if...** - You have already had radiation or systemic chemotherapy for this cancer - You have a permanent metal stent in your bile duct that cannot be removed - You have had prior bile duct reconstruction surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndobiliary 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.

DEVICEPlastic 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.