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Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer (JCOG1113, FUGA-BT)

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Trial Profile

Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer (JCOG1113, FUGA-BT)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Feb 2023

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At a glance

  • Drugs Gimeracil/oteracil/tegafur (Primary) ; Cisplatin; Gemcitabine
  • Indications Adenocarcinoma; Adenosquamous carcinoma; Biliary cancer; Carcinoma; Cholangiocarcinoma; Gallbladder cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms FUGA-BT

    • Most Recent Events

    • 21 Jan 2023 Results of exploratory analysis of JCOG1113 (n=352) assessing to compare clinical features among the primary sites gemcitabine-based chemotherapy in patients with biliary tract cancer, presented at the 2023 Gastrointestinal Cancers Symposium.
    • 22 Jan 2022 Results presented at the 2022 Gastrointestinal Cancers Symposium
    • 17 Jan 2021 Results of exploratory analysis assessing early tumor shrinkage (ETS) depth of response (DpR) and clinical outcomes, presented at the 2021 Gastrointestinal Cancers Symposium.
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