Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma, Cancer, Liver Cancer, Primary Liver Cancer, Hepatoma

Intervention / Treatment
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* Drug: PI-88
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* matched placebo<br>|
| Experimental: 2<br> | Drug: PI-88<br>* 160mg subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival |  | End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | End of study | 
| Time to Recurrence |  | End of Study | 
| Quality of Life |  | End of Study | 
| Safety and Tolerability |  | End of Study | 
| Compliance |  | End of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PI-88, Hepatocellular Carcinoma, Phase III, Adjuvant Therapy, Hepatoma, Liver Cancer