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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

Tracking Information
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
 (submitted: October 19, 2020)
Tumour Non-recurrence Rate [ Time Frame: Week 48 ]
The tumor non-recurrence rate at the end of the 48-week study period
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
Tumour Non-recurrence Rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • 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
  • Survival Rate [ Time Frame: Week 48 ]
    Survival rate at the end of the 48-week study period
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
  • Time to first recurrence
  • Survival Rate
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.

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
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
Study Arms  ICMJE
  • No Intervention: Untreated Control
    Untreated control arm
  • Experimental: 160 mg PI-88/Day
    PI-88 160 mg/day SC injection
    Intervention: Drug: PI-88
  • Experimental: 250 mg PI-88/Day
    PI-88 250 mg/day SC injection
    Intervention: Drug: PI-88
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2020)
Original Enrollment  ICMJE
 (submitted: November 1, 2005)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
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
Principal Investigator: Pei-Jer Chen, MD, PhD National Taiwan University Hospital
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