Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced HCC (Hepatocellular Carcinoma) Not Eligible to Curative Approach. A Phase II-b Study.
Patients at an intermediate stage (BCLC-B) are currently offered trans-arterial
chemoembolisation (TACE) as the standard of care. A recent meta-analysis showed that
radioembolization with beta-emitting Yttrium-90-loaded glass microspheres (TheraSphere®) in
patients with HCC achieves a median objective response in 79% of cases (range 29-88%) and
median survival exceeding 15 months has been reported in patients at intermediate stages who
have been treated with TheraSphere®.
In patients with HCC at an advanced stage (BCLC-C) the single treatment that has shown a
statistical advantage on overall survival and disease progression is sorafenib, that
provides a median survival of 10.7 months. Based on the results reported in literature, the
estimated median expected survival of patients with advanced HCC treated by TheraSphere® can
be as long as 12 months.
After approval on July 2007 of a treatment protocol of Y-90 for compassionate use by the
institutional IRB, at the National Cancer Institute of Milan 40 consecutive patients have
been treated with radioembolization with Yttrium-90 microspheres (Theraspheres®) according
to the same guidelines of the present prospective phase II protocol. The initial series of
40 patients treated according to a compassionate use of Y-90 has been instrumental for the
assessment of the procedure's safety and tolerability. The present study has been targeted
to 60 cases including the fist series of 40 "compassionate" patients, due to their adherence
to the same inclusion/exclusion criteria of the proposed phase II study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression (TTP)
At 1, 3, 6, 12 months and every 6 months thereafter
Vincenzo Mazzaferro, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
Italy: National Institute of Health