PI-88 in Hepatocellular Carcinoma After Hepatectomy

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medigen Biotechnology Corporation; Progen Pharmaceuticals
• Collaborators: Medigen Biotechnology Corporation; Progen Pharmaceuticals

Criteria

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.