Condition: Extrahepatic Cholangiocarcinoma · Sponsor: Aichi Medical University
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.
This description comes directly from the study's public registry record.
Tadahisa Inoue · +81561623311 · tinoue-tag@umin.ac.jp
Always discuss trial participation with your own doctor first.
| 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 |
| Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine | Seoul, South Korea | Recruiting |
| Severance Hospital, Yonsei University College of Medicine | Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07235007