Cancer, Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Primary Liver Cancer
Conditions
Keywords
Hepatocellular Carcinoma, PI-88, Phase III, Adjuvant Therapy, Hepatoma, Liver Cancer
Brief 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.
Interventions
DRUGPI-88
160mg subcutaneous injection
DRUGplacebo
matched placebo
Sponsors
Progen Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free Survival | End of Study |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life | End of Study |
| Safety and Tolerability | End of Study |
| Compliance | End of Study |
| Overall Survival | End of study |
| Time to Recurrence | End of Study |
Countries
Australia, Canada, Hong Kong, Italy, Malaysia, Singapore, Spain, Taiwan, Thailand, United States
Outcome results
None listed