A Randomized, Multi-Centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is
rarely cured and recurs frequently after regional therapy or transplantation. Hepatic
resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC
have been detected by molecular techniques in 88% of patients at the time of surgery, and
probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a
curative resection have been tried, including various regimens of adjuvant and neoadjuvant
In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for
HCC patients after curative hepatic resection. The efficacy endpoints, including tumour
non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated.
Several risk factors associated with tumour recurrence are also being analysed.
There are two stages to this study. In stage 1 there are three arms - untreated control and
two arms are two different PI-88 dose. In stage 2 the better of the two PI-88 arms will be
continued against the control arm.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumour non-recurrence rate
Pei-Jer Chen, MD, PhD
National Taiwan University Hospital
United States: Food and Drug Administration