Repeated endobiliary radiofrequency ablation with durvalumab, gemcitabine, and cisplatin for unresectable extrahepatic bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BRAVE is an open-label, randomized multicenter trial that assigns patients 1:1 to repeated endobiliary radiofrequency ablation (EB-RFA) with plastic stent placement or to plastic stenting alone, with all participants receiving first-line durvalumab plus gemcitabine and cisplatin (GCD). A planned second endoscopic session at month 3 (window 2–4 months) allows repeat EB-RFA in the EB-RFA arm and standardized stent management in both arms, and additional EB-RFA sessions (≥2-month intervals) are permitted if imaging suggests an ablatable lesion. The primary endpoint is overall survival, and secondary endpoints include time to recurrent biliary obstruction, progression-free survival, adverse events, and technical/clinical success. The trial builds on retrospective multicenter data suggesting a survival benefit with repeated EB-RFA but will provide prospective randomized evidence integrated with modern immunochemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

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.

Where it's running

• Aichi Medical University
  Aichi, Japan Recruiting
• Nagoya City University Hospital
  Aichi, Japan Recruiting
• Nagoya City University Midori Municipal Hospital
  Aichi, Japan Recruiting
• Gifu University Hospital
  Gifu, Japan Recruiting
• Pusan National University Hospital
  Busan, South Korea Recruiting
• Gangnam Severance Hospital, Yonsei University College of Medicine
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Tadahisa Inoue, Associate Professor — Department of Gastroenterology, Aichi Medical University
• Study coordinator: Tadahisa Inoue
• Email: tinoue-tag@umin.ac.jp
• Phone: +81561623311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.