Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
Hepatocellular carcinoma is one of the most prevalent primary cancers in many countries. In
France, mortality due to HCC on viral C cirrhosis is going to increase of about 150% for men
and 200% for women until 2020. Consequently, HCC is a problem of public health.
The current treatment for HCC is mainly palliative with chemoembolization or intra-arterial
radiotherapy, and intra-arterial targeted radiotherapy being the best tolerated method
(iodine-131-labelled lipiodol being the most commonly used).
However, since 2007, a new therapeutic approach can be considered with oral sorafenib, an
anti-angiogenic drug which increases slightly the survival of patients.
The key for an efficient treatment of HCC is presumably a co-treatment of sorafenib and
intra-arterial radiotherapy. The 131I-lipiodol is a good candidate but presents
disadvantages: it requires hospitalization in a radionuclide therapy room for one week.
Therefore, it is necessary to find new radioactive labellings for lipiodol. In this
objective, 188Re-SSS lipiodol, a new radioactive labeled stable complex has been developed.
It has a short half-life and a tiny amount of gamma radiation compared to 131I-lipiodol, so
it allows to reduce hospitalization in a protected room from 8 days to only one day.
The aim of this study is to determine the Maximum Tolerated Dose and thus the recommended
activity of 188Re-SSS lipiodol by intra-arterial injection in patients with HCC.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximal tolerated dose
Toxicity CTC grade ≥ 3 with CTCAE version 4.
Injection each week during 4 weeks and at month 2
Etienne GARIN, MD, PhD
Centre Eugene Marquis
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)