Clinical trial · Interventional
PI-88 in Hepatocellular Carcinoma After Hepatectomy
A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
NCT00247728CI-TRIAL-00059276completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PI-88 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Untreated Control
- description
- Untreated control arm
- type
- EXPERIMENTAL
- label
- 160 mg PI-88/Day
- description
- PI-88 160 mg/day SC injection
- interventionNames
- Drug: PI-88
- type
- EXPERIMENTAL
- label
- 250 mg PI-88/Day
- description
- PI-88 250 mg/day SC injection
- interventionNames
- Drug: PI-88
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLiu CJ, Chang J, Lee PH, Lin DY, Wu CC, Jeng LB, Lin YJ, Mok KT, Lee WC, Yeh HZ, Ho MC, Yang SS, Yang MD, Yu MC, Hu RH, Peng CY, Lai KL, Chang SS, Chen PJ. Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence. World J Gastroenterol. 2014 Aug 28;20(32):11384-93. doi: 10.3748/wjg.v20.i32.11384. PMID 25170226
- DERIVEDLiu CJ, Lee PH, Lin DY, Wu CC, Jeng LB, Lin PW, Mok KT, Lee WC, Yeh HZ, Ho MC, Yang SS, Lee CC, Yu MC, Hu RH, Peng CY, Lai KL, Chang SS, Chen PJ. Heparanase inhibitor PI-88 as adjuvant therapy for hepatocellular carcinoma after curative resection: a randomized phase II trial for safety and optimal dosage. J Hepatol. 2009 May;50(5):958-68. doi: 10.1016/j.jhep.2008.12.023. Epub 2009 Feb 15. PMID 19303160