The purpose of this study is to assess the effectiveness of an investigational drug called ADI-PEG20 in patients with advanced hepatocellular carcinoma (liver cancer) that has not responded to systemic therapy. In prior studies, some patients have experienced tumor shrinkage and have lived longer than anticipated.
ADI-PEG20 causes a nutrient called arginine to break down. Liver cancer cells require arginine to survive. By depriving liver cancer cells of arginine, ADI-PEG20 may prevent them from growing. This is complemented by the lack of a replenishing mechanism of arginine in liver cancer cells compared to normal cells.
In this study, patients will be randomly assigned in a 2:1 fashion to receive ADI-PEG20 plus best supportive care, or a placebo plus best supportive care.