Conditions: Carcinoma, Hepatocellular
Keywords: PI-88 post resection hepatoma adjuvant therapy hepatectomy hepatoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Untreated control arm arm 2: PI-88 160 mg/day SC injection arm 3: PI-88 250 mg/day SC injection

Interventions: intervention 1: PI-88
Intervention descriptions: intervention 1: Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

Protocol document: