search
Back to results

PI-88 in Hepatocellular Carcinoma After Hepatectomy

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
PI-88
Sponsored by
Cellxpert Biotechnology Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Untreated Control

160 mg PI-88/Day

250 mg PI-88/Day

Arm Description

Untreated control arm

PI-88 160 mg/day SC injection

PI-88 250 mg/day SC injection

Outcomes

Primary Outcome Measures

Tumour Non-recurrence Rate
The tumor non-recurrence rate at the end of the 48-week study period

Secondary Outcome Measures

Time to Recurrence
Time to recurrence during the 48-week study period
Survival Rate
Survival rate at the end of the 48-week study period

Full Information

First Posted
November 1, 2005
Last Updated
June 21, 2022
Sponsor
Cellxpert Biotechnology Corp.
Collaborators
Medigen Biotechnology Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00247728
Brief Title
PI-88 in Hepatocellular Carcinoma After Hepatectomy
Official Title
A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellxpert Biotechnology Corp.
Collaborators
Medigen Biotechnology Corporation

4. Oversight

5. Study Description

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-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy. In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
PI-88, post resection hepatoma, adjuvant therapy, hepatectomy, hepatoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Untreated Control
Arm Type
No Intervention
Arm Description
Untreated control arm
Arm Title
160 mg PI-88/Day
Arm Type
Experimental
Arm Description
PI-88 160 mg/day SC injection
Arm Title
250 mg PI-88/Day
Arm Type
Experimental
Arm Description
PI-88 250 mg/day SC injection
Intervention Type
Drug
Intervention Name(s)
PI-88
Intervention Description
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
Primary Outcome Measure Information:
Title
Tumour Non-recurrence Rate
Description
The tumor non-recurrence rate at the end of the 48-week study period
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Time to Recurrence
Description
Time to recurrence during the 48-week study period
Time Frame
until confirmed tumour recurrence, or for a maximum of 48 weeks
Title
Survival Rate
Description
Survival rate at the end of the 48-week study period
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Jer Chen, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813-46
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital-Linkou Medical Centre
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25170226
Citation
Liu 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.
Results Reference
derived
PubMed Identifier
19303160
Citation
Liu 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.
Results Reference
derived

Learn more about this trial

PI-88 in Hepatocellular Carcinoma After Hepatectomy

We'll reach out to this number within 24 hrs