PI-88 in Hepatocellular Carcinoma After Hepatectomy
Carcinoma, Hepatocellular

About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring PI-88, post resection hepatoma, adjuvant therapy, hepatectomy, hepatoma
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.
Sites / Locations
- Kaohsiung Veterans General Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Chang Gung Memorial Hospital-Linkou Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Untreated Control
160 mg PI-88/Day
250 mg PI-88/Day
Untreated control arm
PI-88 160 mg/day SC injection
PI-88 250 mg/day SC injection