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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

172

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2004

Typical duration for phase_2

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

June 1, 2004

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed

12.5 years until next milestone

Results Posted

Study results publicly available

November 12, 2020

Completed

Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

4 years

First QC Date

November 1, 2005

Results QC Date

July 27, 2011

Last Update Submit

June 21, 2022

Conditions

Carcinoma, Hepatocellular

Keywords

PI-88post resection hepatomaadjuvant therapyhepatectomyhepatoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Time to Recurrence
until confirmed tumour recurrence, or for a maximum of 48 weeks
Survival Rate
Week 48

Study Arms (3)

Untreated Control

NO INTERVENTION

Untreated control arm

160 mg PI-88/Day

EXPERIMENTAL

PI-88 160 mg/day SC injection

Drug: PI-88

250 mg PI-88/Day

EXPERIMENTAL

PI-88 250 mg/day SC injection

Drug: PI-88

Interventions

PI-88DRUG

Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

160 mg PI-88/Day250 mg PI-88/Day

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
+1 more criteria

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Cellxpert Biotechnology Corp.lead
Medigen Biotechnology Corporationcollaborator

Study Sites (6)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813-46, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Memorial Hospital-Linkou Medical Centre

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

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.
PMID: 25170226DERIVED
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.
PMID: 19303160DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

phosphomannopentaose sulfate

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Results Point of Contact

Title: Director of Regulatory Affairs and Clinical Development
Organization: Progen Pharmaceuticals Ltd

Study Officials

Pei-Jer Chen, MD, PhD
National Taiwan University Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

June 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 23, 2022

Results First Posted

November 12, 2020

Record last verified: 2022-06

Locations

TW(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

Untreated Control

160 mg PI-88/Day

250 mg PI-88/Day

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations