PI-88 in Hepatocellular Carcinoma After Hepatectomy
The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Multi-Centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study|
- Tumour non-recurrence rate
- Time to first recurrence
- Survival rate
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||June 2008|
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 therapy.
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.
|Kaohsiung Veterans General Hospital|
|Kaohsiung, Taiwan, 813-46|
|Chang Gung Memorial Hospital-Linkou Medical Centre|
|Kwei-Shan, Taiwan, 333|
|Taichung Veterans General Hospital|
|Taichung, Taiwan, 407|
|China Medical University Hospital|
|Taichung, Taiwan, 404|
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 704|
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Pei-Jer Chen, MD, PhD||National Taiwan University Hospital|