PI-88 in Hepatocellular Carcinoma After Hepatectomy

June 21, 2022 updated by: Cellxpert Biotechnology Corp.

A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813-46
        • Kaohsiung Veterans General Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital-Linkou Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Untreated Control
Untreated control arm
Experimental: 160 mg PI-88/Day
PI-88 160 mg/day SC injection
Drug: PI-88
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
Experimental: 250 mg PI-88/Day
PI-88 250 mg/day SC injection
Drug: PI-88
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour Non-recurrence Rate
Time Frame: Week 48
The tumor non-recurrence rate at the end of the 48-week study period
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recurrence
Time Frame: until confirmed tumour recurrence, or for a maximum of 48 weeks
Time to recurrence during the 48-week study period
until confirmed tumour recurrence, or for a maximum of 48 weeks
Survival Rate
Time Frame: Week 48
Survival rate at the end of the 48-week study period
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellxpert Biotechnology Corp.

Collaborators

Medigen Biotechnology Corporation

Investigators

  • Principal Investigator: Pei-Jer Chen, MD, PhD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG 002
  • PR88204 (Other Identifier: Alternate protocol identifier set by company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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