Heparanase inhibitor PI-88 as adjuvant therapy for hepatocellular carcinoma after curative resection: a randomized phase II trial for safety and optimal dosage

CJ Liu, PH Lee, DY Lin, CC Wu, LB Jeng, PW Lin… - Journal of …, 2009 - Elsevier
BACKGROUND/AIMS: Hepatocellular carcinoma recurrence after curative treatment
adversely influences clinical outcome. It is important to explore adjuvant therapies. This
phase II/stage 1 multi-center, randomized trial investigated the safety, optimal dosage and
preliminary efficacy of PI-88, a novel heparanase inhibitor, in the setting of post-operative
recurrence of HCC in according to a Simon's 2-stage design. METHODS: Three groups were
included: one untreated arm (Group A) and two PI-88 arms (Group B: 160mg/day; Group C …