Abstract:
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 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: 160 mg/day; Group C: 250 mg/day). Treatment groups received PI-88 over nine 4-week treatment cycles, followed by a 12-week treatment-free period. Safety and optimal dosage were assessed. RESULTS:Overall, 172 patients were randomized and 168 were included in the intention-to-treat (ITT) population. Treatment-related adverse effects included cytopenia, injection site hemorrhage, PT prolongation, etc. Four serious adverse events were possibly related to PI-88 treatment. One (1.8%) group B patients and six (10.5%) group C had hepatotoxicity-related withdrawals. Among the ITT population, 29 patients (50%) in Group A, 35 (63%) in Group B, and 22 (41%) in Group C remained recurrence-free at completion. Calculated T(1) value suggested 160 mg/day treatment satisfied the criteria for the next stage of the trial. CONCLUSIONS:PI-88 at 160 mg/day is optimal and safe, and shows preliminary efficacy as an adjunct therapy for post-operative HCC.
journal_name
J Hepatoljournal_title
Journal of hepatologyauthors
Liu CJ,Lee PH,Lin DY,Wu CC,Jeng LB,Lin PW,Mok KT,Lee WC,Yeh HZ,Ho MC,Yang SS,Lee CC,Yu MC,Hu RH,Peng CY,Lai KL,Chang SS,Chen PJdoi
10.1016/j.jhep.2008.12.023subject
Has Abstractpub_date
2009-05-01 00:00:00pages
958-68issue
5eissn
0168-8278issn
1600-0641pii
S0168-8278(09)00056-7journal_volume
50pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND/AIMS:Central nervous system abnormalities such as fatigue and depression occur more frequently in chronic hepatitis C virus (HCV) infection than in many other causes of chronic liver disease. The finding that fatigue is unrelated to activity of hepatitis or mode of infection could indicate an independent eff...
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更新日期:2010-10-01 00:00:00
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