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PI-88 in Hepatocellular Carcinoma After Hepatectomy

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: NCT00247728
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Progen Pharmaceuticals
Information provided by (Responsible Party):
Medigen Biotechnology Corporation

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: PI-88 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
Study Start Date : June 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
No Intervention: Untreated Control
Untreated control arm
Experimental: 160 mg PI-88/Day
PI-88 160 mg/day SC injection
Drug: PI-88
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

Experimental: 250 mg PI-88/Day
PI-88 250 mg/day SC injection
Drug: PI-88
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

Primary Outcome Measures :
  1. Tumour Non-recurrence Rate [ Time Frame: Week 48 ]
    The tumor non-recurrence rate at the end of the 48-week study period

Secondary Outcome Measures :
  1. Time to Recurrence [ Time Frame: until confirmed tumour recurrence, or for a maximum of 48 weeks ]
    Time to recurrence during the 48-week study period

  2. Survival Rate [ Time Frame: Week 48 ]
    Survival rate at the end of the 48-week study period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients have voluntarily given written informed consent
  • Age ≥ 18 years but ≤ 75 years
  • Males or females
  • Histological diagnosis of hepatocellular carcinoma
  • Curative hepatectomy within the past 4-6 weeks
  • ECOG performance status of 0 to 2
  • Cardiac functional capacity ≤ to class II (New York Heart Association)
  • Patients with adequate renal, hepatic, and haematopoietic function as defined by:

    • Serum creatinine ≤ 2.0 mg/dL
    • Total bilirubin < 2.5 mg/dL
    • Neutrophil count > 1.5 x 10^9/L
    • ALT < 5 x upper limit of normal (ULN)
    • White blood cell (WBC) count ≥ 3 x 10^9/L
    • Platelet count ≥ 80 x 10^9/L
    • Prothrombin time international normalized ratio (PT-INR) ≤ 1.3 (or PT-INR ≤ 1.4 but PT within normal range)
    • Activated partial thromboplastin time (APTT) < ULN

Exclusion Criteria:

  • Patients with history of allergy and/or hypersensitivity to anticoagulants/thrombolytic agents, especially heparin.
  • Patients with history of immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or other platelet disease
  • Patients with previous positive result in a heparin-induced thrombocytopenia (HIT) antibody test.
  • Patients with any tumour metastasis.
  • Patients with uncontrolled infection or serious infection within the past 4 weeks.
  • Patients with myocardial infarction, stroke, or congestive heart failure within the past 3 months.
  • Patients with history of inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
  • Patients with acute or chronic gastrointestinal bleeding within the past 1 year.
  • Patients with a history of drug abuse or psychiatric disorder.
  • Patients with known HIV infection or AIDS-related illness.
  • Patients who received other investigational or anti-neoplastic medication within the past 4 weeks.
  • Use of aspirin, aspirin-containing medications, non-steroidal anti-inflammatory drugs (except for COX-2 inhibitors), heparin, low molecular weight heparin, warfarin, anti-platelet drugs, or any other anticoagulant medications 2 weeks prior to or during the study period.
  • Women who are pregnant or breast-feeding.
  • Women of child-bearing potential who are not using an adequate method of contraception.

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): NCT00247728

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Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813-46
China Medical University Hospital
Taichung, Taiwan, 404
Taichung Veterans General Hospital
Taichung, Taiwan, 407
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Chang Gung Memorial Hospital-Linkou Medical Centre
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Medigen Biotechnology Corporation
Progen Pharmaceuticals
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Principal Investigator: Pei-Jer Chen, MD, PhD National Taiwan University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medigen Biotechnology Corporation Identifier: NCT00247728    
Other Study ID Numbers: MG 002
PR88204 ( Other Identifier: Alternate protocol identifier set by company )
First Posted: November 2, 2005    Key Record Dates
Results First Posted: November 12, 2020
Last Update Posted: November 12, 2020
Last Verified: October 2020
Keywords provided by Medigen Biotechnology Corporation:
post resection hepatoma
adjuvant therapy
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases