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NCT07235007Recruiting

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)

Source: ClinicalTrials.gov · Last updated 13 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
16 Nov 2025
Start date
20 Nov 2025
Primary completion date
31 Dec 2027
Lead sponsor
Aichi Medical University
NCT number
NCT07235007

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 20 Nov 2025 to the primary completion date, 31 Dec 2027
  • 8 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior radiotherapy or systemic therapy for the current eCCA.
  • Surgically altered anatomy except for Billroth-I; prior biliary reconstruction.

Other illness

  • History of chronic cholangitis (e.g., primary sclerosing cholangitis, IgG4-related cholangitis).
  • Any condition judged unsuitable by the investigator.

Other

  • Presence of a self-expanding metal stent that cannot be endoscopically removed.
  • Expected survival \<3 months.
  • Inability to insert an oral endoscope or reach the papilla.
  • Contraindication to endobiliary RFA.
  • Pregnancy or possible pregnancy.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aichi Medical University
Coordinator of this site? Confirm its status
AichiJapanRecruiting
Nagoya City University Hospital
Coordinator of this site? Confirm its status
AichiJapanRecruiting
Nagoya City University Midori Municipal Hospital
Coordinator of this site? Confirm its status
AichiJapanRecruiting
Gifu University Hospital
Coordinator of this site? Confirm its status
GifuJapanRecruiting
Pusan National University Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaRecruiting
Severance Hospital, Yonsei University College of Medicine
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Gangnam Severance Hospital, Yonsei University College of Medicine
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.