Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that patient treatments have begun in the Company’s second global US registration trial investigating Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) in the treatment of patients with intrahepatic cholangiocarcinoma (ICC).
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 trial’s first patient and treatments have begun by a team led by Dr. Evan S. Glazer. Dr. Glazer, a board certified surgical oncologist, is the principal investigator for the trial at the UTHSC/MUH/WCC location.
The trial, entitled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.