Status:
COMPLETED
PI-88 in Hepatocellular Carcinoma After Hepatectomy
Lead Sponsor:
Cellxpert Biotechnology Corp.
Collaborating Sponsors:
Medigen Biotechnology Corporation
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00247728
Start Date
June 1 2004
End Date
June 1 2008
Last Update
June 23 2022
Active Locations (6)
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1
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813-46
2
China Medical University Hospital
Taichung, Taiwan, 404
3
Taichung Veterans General Hospital
Taichung, Taiwan, 407
4
National Cheng Kung University Hospital
Tainan, Taiwan, 704