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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-07-31

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.

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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.

Conditions

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Cancer Liver Cancer Primary Liver Cancer Hepatocellular Carcinoma Hepatoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matched placebo

2

Group Type EXPERIMENTAL

PI-88

Intervention Type DRUG

160mg subcutaneous injection

Interventions

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PI-88

160mg subcutaneous injection

Intervention Type DRUG

placebo

matched placebo

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No