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A Randomized, Multi-Centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study

Phase 2
18 Years
75 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

A Randomized, Multi-Centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study

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

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.

There are two stages to this study. In stage 1 there are three arms - untreated control and
two arms are two different PI-88 dose. In stage 2 the better of the two PI-88 arms will be
continued against the control arm.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumour non-recurrence rate

Principal Investigator

Pei-Jer Chen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital


United States: Food and Drug Administration

Study ID:

MG 002



Start Date:

June 2004

Completion Date:

June 2008

Related Keywords:

  • Carcinoma, Hepatocellular
  • PI-88
  • post resection hepatoma
  • adjuvant therapy
  • hepatectomy
  • hepatoma
  • Carcinoma
  • Carcinoma, Hepatocellular