Date: 2015-10-15
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Delcath Systems (USA - NY)
Product: Hepatic CHEMOSAT® Delivery System for Melphalan
Action
mechanism: CHEMOSAT® is a platform for the administration of chemosaturation therapy to the liver. The system delivers a chemotherapeutic agent (melphalan hydrochloride) directly to the liver using a procedure known as percutaneous hepatic perfusion (PHP). The system uses catheters placed to isolate the liver’s blood flow from the rest of the body and proprietary filters to reduce the concentration of the chemotherapeutic agent (melphalan hydrochloride) after it leaves the target organ. With CHEMOSAT®, doctors can administer concentrated doses of a chemotherapeutic agent while limiting chemotherapy-related toxicities at a manageable level. A CHEMOSAT® procedure is minimally-invasive and can be repeated.
Disease: unresectable hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On October 15, 2015, Delcath Systems, a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announced that the first treatment with the Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT) has been performed in the intrahepatic cholangiocarcinoma (ICC) cohort of the Company\'s global Phase 2 clinical trial program for treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer or HCC) and ICC. A team led by Prof. Thomas J. Vogl, M.D., Director of the Institute for Diagnostic and Interventional Radiology of Johannes Wolfgang Goethe University Hospital, Frankfurt, Germany, treated its first patient on October 13, 2015. The ICC cohort of the Phase 2 program is designed to investigate the efficacy and safety of CHEMOSAT treatment in patients with unresectable ICC confined to the liver. The study is being conducted at the same hospitals in Europe participating in the Company\'s Phase 2 HCC trial. The global Phase 2 HCC/ICC program is evaluating tumor response (objective response rate) as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), and will assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by CHEMOSAT, as well as to assess patient-reported clinical outcomes, or quality-of-life.
