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Gemcitabine, alone or in combination with cisplatin, in patients with advanced or metastatic cholangiocarcinomas and other biliary tract tumours: a multicentre, randomised, phase III study

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Trial Profile

Gemcitabine, alone or in combination with cisplatin, in patients with advanced or metastatic cholangiocarcinomas and other biliary tract tumours: a multicentre, randomised, phase III study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2023

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At a glance

  • Drugs Gemcitabine (Primary) ; Cisplatin
  • Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ABC-01; ABC-02

    • Most Recent Events

    • 24 Oct 2023 Results of post hoc analysis (n=534 from ABC-01, 02 and 03 study) assessing reference survival data for patients with advanced eCCA treated with first-line cisplatin-gemcitabine (CisGem) chemotherapy within the prospective, randomised Advanced Biliary tract Cancer studies presented at the 48th European Society for Medical Oncology Congress
    • 25 Jan 2020 Results (N=994), post hoc analysis evaluated differences by sex in the frequency of adverse events and overall survival and its impact on progression-free survival /recurrence-free survival in biliary tract cancer, presented at the 2020 Gastrointestinal Cancers Symposium
    • 11 May 2019 Results of post hoc analysis aiming to provide reference survival data to inform the design, sample size calculation and feasibility of future studies exploring the role of systemic (including targeted) therapies and LDT in advanced iCCA using data from ABC-01, 02 and 03 study published in the Journal of the National Cancer Institute

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