Clinical Trials Directory

Trials / Terminated

TerminatedNCT01402908

A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection

A Prospective, Randomized, Double-blind, Placebo Controlled, Parallel-group, International Multicenter Phase III Trial of PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
520 (actual)
Sponsor
Cellxpert Biotechnology Corp. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPI-88Lyophilized powder reconstituted to provide 160 mg of PI-88
OTHERPlaceboLactose lyophilized powder

Timeline

Start date
2011-08-01
Primary completion
2014-07-01
Completion
2015-01-01
First posted
2011-07-26
Last updated
2022-06-23
Results posted
2020-12-30

Locations

25 sites across 4 countries: China, Hong Kong, South Korea, Taiwan

Source: ClinicalTrials.gov record NCT01402908. Inclusion in this directory is not an endorsement.