Delcath Systems announced that the intrahepatic cholangiocarcinoma (ICC) study cohort of its expanded Global Phase II Clinical Trial Program of Melphalan/HDS for use in the treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer, or HCC) has opened for patient enrollment.
The ICC study will be conducted at the same hospitals in Europe participating in the Company’s Phase 2 HCC trial, and ICC enrollment is now open at Goethe University Hospital in Frankfurt, the Medical School Hannover and Jena University Hospital.
Additional centers in Germany as well as centers in the United Kingdom are expected to open for enrollment in the coming weeks.
ICC is a tumor in the bile duct that arises within the liver. It is the second most common primary liver tumor and represents approximately 15% of new HCC cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.
The ICC cohort of the Phase 2 trial will investigate the safety and efficacy of Melphalan/HDS treatment in patients with unresectable ICC confined to the liver.
This cohort will evaluate 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 Melphalan/HDS, as well as to assess patient-reported clinical outcomes, or quality-of-life.
"We believe our Melphalan/HDS treatment may offer significant clinical benefit for ICC patients who face limited treatment options," said Jennifer Simpson, Ph.D., Interim President and CEO of Delcath Systems. "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."