PI-88 in Hepatocellular Carcinoma After Hepatectomy
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ClinicalTrials.gov Identifier: NCT00247728 |
Recruitment Status :
Completed
First Posted : November 2, 2005
Results First Posted : November 12, 2020
Last Update Posted : November 12, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | November 1, 2005 | |||
First Posted Date ICMJE | November 2, 2005 | |||
Results First Submitted Date ICMJE | July 27, 2011 | |||
Results First Posted Date ICMJE | November 12, 2020 | |||
Last Update Posted Date | November 12, 2020 | |||
Study Start Date ICMJE | June 2004 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Tumour Non-recurrence Rate [ Time Frame: Week 48 ] The tumor non-recurrence rate at the end of the 48-week study period
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Original Primary Outcome Measures ICMJE |
Tumour Non-recurrence Rate | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | PI-88 in Hepatocellular Carcinoma After Hepatectomy | |||
Official Title ICMJE | A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study | |||
Brief Summary | The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy. | |||
Detailed Description | Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy. In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Hepatocellular | |||
Intervention ICMJE | Drug: PI-88
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
172 | |||
Original Enrollment ICMJE |
343 | |||
Actual Study Completion Date ICMJE | June 2008 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00247728 | |||
Other Study ID Numbers ICMJE | MG 002 PR88204 ( Other Identifier: Alternate protocol identifier set by company ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Medigen Biotechnology Corporation | |||
Study Sponsor ICMJE | Medigen Biotechnology Corporation | |||
Collaborators ICMJE | Progen Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | Medigen Biotechnology Corporation | |||
Verification Date | October 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |