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Doxorubicin Transdrug®

Phase II/III (BA 2006/03/03) Liver Cancer--Hepatocellular Carcinoma (HCC) (ongoing)

Doxorubicin Transdrug® has been granted Orphan Drug Status by the EMEA in Europe and the FDA in the U.S.

This multi-centre randomised Phase II/III clinical trial for the treatment of hepatocarcinoma, conducted versus local standard treatment, will determine the efficacy of doxorubicin Transdrug® administered via hepatic intra-arterial administration in repeated cures (30mg/m2 dosage defined in the previous trial). The efficacy will be assessed firstly, in a first part of the trial, on a number of patients whose disease does not progress within three months (50 patients). In the second part of this same trial, in Phase III, extended to 200 patients, the evaluation will deal concern the criteria of "time without progression of the disease", monitored over 12 months versus local standard treatment.




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BioAlliance Pharma