PI-88 in Hepatocellular Carcinoma After Hepatectomy
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: PI-88
Intervention description: Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PI-88; post resection hepatoma; adjuvant therapy; hepatectomy; hepatoma

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.
    

Eligibility 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.