A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, International, Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma
18 Years
N/A
Both
Cancer, Liver Cancer, Primary Liver Cancer, Hepatocellular Carcinoma, Hepatoma
Trial Information
A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, International, Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma
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.
Key
Inclusion Criteria:
- Histologically-proven primary hepatocellular carcinoma with curative resection
performed in the 4 - 6 weeks prior to randomisation.
- ECOG performance status 0 to 2
- Child Pugh classification A or B
Key Exclusion Criteria:
- Any evidence of tumour metastasis or co-existing malignant disease
- Any prior recurrence of HCC or any liver resection prior to the most recent procedure
- History of prior HCC therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Disease-free Survival
Outcome Time Frame:
End of Study
Safety Issue:
No
Principal Investigator
Ronnie TP Poon, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Hong Kong, Queen Mary Hospital
Authority:
United States: Food and Drug Administration
Study ID:
PR88302
NCT ID:
NCT00568308
Start Date:
December 2007
Completion Date:
July 2008
Related Keywords:
- Cancer
- Liver Cancer
- Primary Liver Cancer
- Hepatocellular Carcinoma
- Hepatoma
- Hepatocellular Carcinoma
- PI-88
- Phase III
- Adjuvant Therapy
- Hepatoma
- Liver Cancer
- Carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Albany, New York 12208 |
