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A Multi-Centre, Randomised, Open-Label, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

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A Multi-Centre, Randomised, Open-Label, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 14 Sep 2023

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At a glance

  • Drugs Fimaporfin/gemcitabine (Primary) ; Cisplatin; Gemcitabine
  • Indications Adenocarcinoma; Cholangiocarcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms RELEASE
  • Sponsors PCI Biotech

    • Most Recent Events

    • 17 Feb 2023 According to a PCI Biotech media release, all major study closure activities for the RELEASE trial are completed and the estimated remaining cash effect for the closure process is less than NOK -1 million. Downsizing of the full clinical team, reported in August, was enacted during second half of 2022 with full cost reduction effect in Q1 2023.
    • 28 Jul 2022 This trial has been completed in Germany (Date of the global end of the trial : 06-May-2022), according to European Clinical Trials Database record.
    • 07 Jul 2022 This trial has been completed in Denmark (Date of the global end of the trial : 06-May-2022), according to European Clinical Trials Database record.

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