NCT00247728

PI-88 in Hepatocellular Carcinoma After Hepatectomy

A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Cellxpert Biotechnology Corp. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	PI-88	Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-11-02
• Last updated: 2022-06-23
• Results posted: 2020-11-12

Locations

6 sites across 1 country: Taiwan