Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of Hepatocellular Carcinoma (HCC)
Status:
Suspended
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma (HCC) is a primary malignant tumor of the liver that accounts for an
important health problem worldwide. In only 10% - 15% of all patients with HCC, tumors are
considered resectable at presentation. In contrast to metastatic liver disease, there is no
role for systemic chemotherapy in the treatment of HCC. Today only evidence is available for
Sorafenib, a tyrosine kinase inhibiting agent. The arsenal of non-surgical therapies can
roughly be divided into local ablative, transarterial and systemic therapies. In well
selected patients, local ablative therapy can offer favorable long term results.
For patients with disease confined to the liver, but locally more advanced, transarterial
treatment modalities are proposed. These therapies exploit the dual blood supply to the
liver. HCC derives its blood supply almost entirely from the hepatic artery, while liver
parenchyma derives > 75% of its blood supply from the portal vein. Antitumoral agents, such
as cytotoxic drugs or radionuclides, can be delivered in close proximity of the tumor.
Examples of transarterial therapies are: transarterial chemoembolization (TACE), bland
transarterial embolization (TAE), transarterial chemoembolization with drug eluting beads
(TACE-DEB) and transarterial radioembolization with Iodine-131 or Yttrium-90.
TACE is currently the gold standard for treatment of patients with intermediate stage HCC,
with a reported median survival of around 17 months. A novel development in the TACE
treatment for HCC is the drug-eluting bead (DEB). Recently performed small clinical trials
reported the efficacy of DEBs in the treatment of intermediate stage HCC, which is
substantially higher compared to conventional TACE.
Yttrium-90 radioembolization (90Y-RE) is a relatively recently developed technique which
implements transarterial administration of minimally embolic microspheres loaded with
Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.
In this study the investigators want to prospectively compare TACE-DEB and 90Y-RE, two novel
treatments that both have theoretical and/or proven advantages compared to the use of
conventional TACE, in patients with intermediate stage HCC.