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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00568308
Recruitment Status : Terminated (Commercial decision to discontinue the study)
First Posted : December 6, 2007
Last Update Posted : June 15, 2011
Information provided by:
Progen Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Cancer Liver Cancer Primary Liver Cancer Hepatocellular Carcinoma Hepatoma Drug: PI-88 Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
matched placebo

Experimental: 2 Drug: PI-88
160mg subcutaneous injection

Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: End of Study ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: End of study ]
  2. Time to Recurrence [ Time Frame: End of Study ]
  3. Quality of Life [ Time Frame: End of Study ]
  4. Safety and Tolerability [ Time Frame: End of Study ]
  5. Compliance [ Time Frame: End of Study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00568308

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United States, New York
United States of America, New York, United States
Australia, Australia
Canada, Canada
Hong Kong
Hong Kong, Hong Kong
Italy, Italy
Malaysia, Malaysia
Singapore, Singapore
Spain, Spain
Taiwan, Taiwan
Thailand, Thailand
Sponsors and Collaborators
Progen Pharmaceuticals
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Principal Investigator: Ronnie TP Poon, MD University of Hong Kong, Queen Mary Hospital
Additional Information:
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Responsible Party: Liz Wilson, Progen Pharmaceuticals Identifier: NCT00568308    
Other Study ID Numbers: PR88302
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011
Keywords provided by Progen Pharmaceuticals:
Hepatocellular Carcinoma
Phase III
Adjuvant Therapy
Liver Cancer
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases