Conditions: Cancer Liver Cancer Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma PI-88 Phase III Adjuvant Therapy Hepatoma Liver Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 520
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Detailed description:
Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Arms:
arm 1: Arm 1 arm 2: Arm 2

Interventions: intervention 1: PI-88 intervention 2: Placebo
Intervention descriptions: intervention 1: Lyophilized powder reconstituted to provide 160 mg of PI-88 intervention 2: Lactose lyophilized powder

Protocol document: