To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
608
E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)
Toronto, Ontario, Canada
E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)
Metz, France
E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)
Milan, Italy
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Survival
Time to distant recurrence of HCC
Time to second primary HCC
Time to development of metastases
Tumour measurements
Tumour marker (alpha-fetoprotein AFP)
Quality of life
Length of hospital stay
Adverse events
Laboratory safety examinations
Dose of Seocalcitol
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E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
Barcelona, Spain
E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
Edinburgh, United Kingdom