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The hypothesis of this study is that the median time to progression in the experimental arm is 2 months as compared to the placebo arm of 1.4 months
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Inclusion criteria
The diagnosis of HCC is made either by histological examination of tumor tissue or imaging evidence of a typical space-occupying lesion in the liver together with a serum AFP concentration of above 500 ng/ml (normal value, 10 ng/ml) in a known carrier of hepatitis B or C, or AFP above 400 ng/ml in non Hepatitis B or C carrier.
Absolute neutrophil count > 1.5 x 109/L Platelets > 50 x 109/L Haemoglobin > 9.0g/dl Total bilirubin < 51umol/L (3 mg /dL) AST (SGOT)/ALT (SGPT) < 5 X institutional ULN Creatinine < 1.5 ULN INR <1.7 or prothrombin time (PT) <4 seconds above ULN
Exclusion criteria
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Data sourced from clinicaltrials.gov
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