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: 21 Jul 2018

At a glance

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

    • 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.
    • 07 May 2018 According to a Delcath Systems media release, the Duke Medical Center in Durham, North Carolina is the first cancer center to open for patient enrollment. Dr. Sabino Zani, a surgical oncologist with Duke Medical Center, is a principal investigator of the study in USA.
    • 07 May 2018 Status changed from not yet recruiting to recruiting, according to a Delcath Systems media release.
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