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 Hepatocellular Carcinoma After Surgical Resection
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Disease-Free Survival (DFS)
To evaluate the efficacy of daily administration of PI-88 versus placebo for the adjuvant treatment of study subjects as measured by DFS during study period
End of study
No
Pei-Jer Chen, MD
Principal Investigator
National Taiwan University Hospital
United States: Food and Drug Administration
CT-PI-31
NCT01402908
August 2011
December 2015
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