Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma (PATHWAY)
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ClinicalTrials.gov Identifier: NCT00568308 |
Recruitment Status
:
Terminated
(Commercial decision to discontinue the study)
First Posted
: December 6, 2007
Last Update Posted
: June 15, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Liver Cancer Primary Liver Cancer Hepatocellular Carcinoma Hepatoma | Drug: PI-88 Drug: placebo | Phase 3 |
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 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1 |
Drug: placebo
matched placebo
|
Experimental: 2 |
Drug: PI-88
160mg subcutaneous injection
|
- Disease-free Survival [ Time Frame: End of Study ]
- Overall Survival [ Time Frame: End of study ]
- Time to Recurrence [ Time Frame: End of Study ]
- Quality of Life [ Time Frame: End of Study ]
- Safety and Tolerability [ Time Frame: End of Study ]
- Compliance [ Time Frame: End of Study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00568308
United States, New York | |
United States of America, New York, United States | |
Australia | |
Australia, Australia | |
Canada | |
Canada, Canada | |
Hong Kong | |
Hong Kong, Hong Kong | |
Italy | |
Italy, Italy | |
Malaysia | |
Malaysia, Malaysia | |
Singapore | |
Singapore, Singapore | |
Spain | |
Spain, Spain | |
Taiwan | |
Taiwan, Taiwan | |
Thailand | |
Thailand, Thailand |
Principal Investigator: | Ronnie TP Poon, MD | University of Hong Kong, Queen Mary Hospital |
Additional Information:
Responsible Party: | Liz Wilson, Progen Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00568308 History of Changes |
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 PI-88 Phase III |
Adjuvant Therapy Hepatoma Liver Cancer |
Additional relevant MeSH terms:
Liver Neoplasms Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |