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Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine Versus Cisplatin/Gemcitabine in Patients With IntraHepatic Cholangiocarcinoma

Trial Profile

Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine Versus Cisplatin/Gemcitabine in Patients With IntraHepatic Cholangiocarcinoma

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 18 Oct 2018

At a glance

  • Drugs Melphalan (Primary) ; Cisplatin; Gemcitabine
  • Indications Cholangiocarcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ALIGN
  • Sponsors Delcath Systems
  • Most Recent Events

    • 18 Oct 2018 According to a Delcath Systems media release, the University of Tennessee Health Science Center (UTHSC) in collaboration with Methodist University Hospital (MUH) and West Cancer Center (WCC) in Memphis, Tennessee have enrolled the first patient and treatments have begun by principal investigator Dr. Evan S. Glazer.
    • 17 Aug 2018 According to a Delcath Systems media release, the trial currently have three centers open for enrollment and will expand to additional centers as appropriate.
    • 10 May 2018 According to Delcath Systems media release, the sequential design of the therapies under investigation in this trial will allow the company to minimize capital investment requirements in 2018. The company is also leveraging the existing network of trial sites from the phase 3 FOCUS trial to rollout this trial protocol as efficiently as possible.
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