Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma

Recruiting now · Not applicable

Conditions studied: Extrahepatic Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT07235007

Run by

Aichi Medical University

People needed

120

Starts

2025-11-20

Expected to finish

2030-12-31

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Aichi Medical University — Aichi, Japan (enrolling)
• Nagoya City University Hospital — Aichi, Japan (enrolling)
• Nagoya City University Midori Municipal Hospital — Aichi, Japan (enrolling)
• Gifu University Hospital — Gifu, Japan (enrolling)
• Pusan National University Hospital — Busan, South Korea (enrolling)
• Gangnam Severance Hospital, Yonsei University College of Medicine — Seoul, South Korea (enrolling)
• Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine — Seoul, South Korea (enrolling)
• Severance Hospital, Yonsei University College of Medicine — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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