Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial
Hepatocellular carcinoma (HCC) is the fifth most common malignancy and the third most common
cause of cancer-related death worldwide. Most of the patients are diagnosed at
intermediate-advanced stage when the sole standard treatment is transarterial
chemoembolization (TACE). In the literature, survival rates in TACE studies vary widely and
finally, there is no suggestion for the best chemotherapeutic agent or the optimal treatment
regimen.
We hypothesise that the use of idarubicin (the most cytotoxic drug on HCC cell lines) in DC
Bead would enhance the efficacy of TACE. The primary objective of the study is to determine
the maximal tolerated dose of idarubicin in DC Bead for chemoembolization of non resectable
non metastatic hepatocellular carcinoma.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity assessed according NCI CTC AE v3.0
Within the first month after chemoembolization
Yes
Laurent BEDENNE, MD Ph.D
Principal Investigator
Centre Hospitalier Universitaire de DIJON
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
IDASPHERE
NCT01040559
December 2009
June 2012
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