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
- Diseases
- Liver and biliary tract cancer
- 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
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aichi Medical University Coordinator of this site? Confirm its status | Aichi | Japan | Recruiting |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Aichi | Japan | Recruiting |
| Nagoya City University Midori Municipal Hospital Coordinator of this site? Confirm its status | Aichi | Japan | Recruiting |
| Gifu University Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Severance Hospital, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Gangnam Severance Hospital, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.