切除不能肝外胆管癌に対する反復胆管内高周波アブレーション＋デュルバルマブ、ゲムシタビン、シスプラチン

基本情報

NCT ID

NCT07235007

ステータス

募集中

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

120

治験依頼者名

Aichi Medical University

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (4)