Enrollment open for phase 2 trial of Melphalan/HDS for HCC

Delcath Systems, Inc. announced the intrahepatic cholangiocarcinoma study cohort of its global phase 2 trial of Melphalan/HDS therapy for the treatment of unresectable hepatocellular carcinoma is now enrolling patients, according to a press release.

The trial will investigate the safety and efficacy of melphalan/HDS therapy (melphalan hydrochloride for injection with the hepatic delivery system, Delcath) in patients with unresectable intrahepatic cholangiocarcinoma (ICC) confined to the liver. The melphalan/HDS is a system designed to supply high-dose chemotherapy to the liver while controlling systemic exposure, according to the Delcath website.

The trial will also evaluate tumor response through modified Response Evaluation Criteria in Solid Tumor, and will assess progression-free survival and safety, according to the release.

“We believe our melphalan/HDS treatment may offer significant clinical benefit for ICC patients who face limited treatment options,” Jennifer Simpson, PhD, interim president and chief executive officer of Delcath, said in the release. “A positive efficacy signal may provide a regulatory pathway to a U.S. registration trial, and consolidated safety data from the HCC and ICC cohorts of this global phase 2 trial will offer valuable information for us to provide to the FDA.” – by Melinda Stevens

Disclosure: Simpson is an employee of Delcath.