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โ† Trials
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Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma

RecruitingNAAges 18 Years - anyAllAichi Medical University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ18 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.
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What it tests

  • Endobiliary Radiofrequency Ablation (EB-RFA)
  • Plastic Biliary Stent
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Where

8 sites
Aichi Medical University
Aichi, Japan
Nagoya City University Hospital
Aichi, Japan
Nagoya City University Midori Municipal Hospital
Aichi, Japan
Gifu University Hospital
Gifu, Japan
Pusan National University Hospital
Busan, South Korea
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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