Riccardo Lencioni, principal investigator, previews new liver cancer study hqTACE in a proposed international clinical trial currently under FDA review. BioSphere Medical has submitted the proposed protocol to the FDA for approval.
Liver cancer is on the rise and emerging therapies for treating it was a focus of the recent 2010 international symposium on Clinical Interventional Oncology (CIO). Riccardo Lencioni, radiologist and principal investigator of a BioSphere Medical proposed international phase 3 liver cancer treatment study that is under FDA review – the HiQUALITY HepaSphere/QuadraSphere in Liver Cancer Treatment) clinical trial – presented a preview of the protocol and design. The trial is being designed to compare the treatment of patients with localised, non-resectable hepatocellular carcinoma (HCC), the most common form of liver cancer, with either conventional transarterial chemoembolization (cTACE) or doxorubicin-loaded HepaSphere/QuadraSphere Microspheres transarterial chemoembolization (hqTACE). BioSphere sponsored the symposium and has submitted the proposed clinical trial that evaluates the effectiveness and safety of its microsphere product to the FDA for approval. Currently in the United States, no embolic is approved for liver cancer. This would be the first phase III embolotherapy study for the treatment of liver cancer in the United States, if approved by the FDA.
“This is a rigorously designed study following highest recommendations for hepatocellular research. It is very important to produce good data in line with evidence-based medicine and best standards,” said Lencioni. “This is an important hqTACE study to further our development of improved patient care and outcomes.”
Liver cancer is the third leading cause of cancer deaths worldwide. The sharp rise in hepatitis C infections, alcohol consumption and obesity is reported as a key contributing factor to the increase in liver cirrhosis and liver cancer. Liver transplantation or tumour resection is considered potentially a curative treatment; however, only about 25% of liver cancers are diagnosed when they can be treated surgically.
HepaSphere Microspheres are approved throughout Europe for treatment of liver cancer with and without doxorubicin delivery (http://www.biospheremed.com/international/index.cfm). In the United States, the microspheres are marketed as QuadraSphere and are approved for embolization of hypervascularised tumours and peripheral arteriovenous malformations. Although marketed differently, QuadraSphere and HepaSphere Microspheres are identical microspheres designed for controlled, targeted embolization. They are biocompatible, hydrophilic, non-resorbable, and conform to the vessel walls for excellent occlusion.