Carcinoma, HepatocellularPhase 2NCT00247728
PI-88 in Hepatocellular Carcinoma After Hepatectomy
A Phase 2 study testing PI-88 in people with Carcinoma, Hepatocellular, run by Cellxpert Biotechnology Corp. at 6 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- PI-88
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 6 sitesTaiwan
- Study dates
- Jun 2004to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Kaohsiung Veterans General Hospital
Kaohsiung City, 813-46
China Medical University Hospital
Taichung, 404
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Chang Gung Memorial Hospital-Linkou Medical Centre
Taoyuan, 333
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- PI-88
- Keywords
- PI-88, post resection hepatoma, adjuvant therapy, hepatectomy, hepatoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI-88Drug
Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Untreated Control | No intervention | Untreated control arm |
| 160 mg PI-88/Day | Experimental | PI-88 160 mg/day SC injection Receives: Drug: PI-88 |
| 250 mg PI-88/Day | Experimental | PI-88 250 mg/day SC injection Receives: Drug: PI-88 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour Non-recurrence Rate
The tumor non-recurrence rate at the end of the 48-week study period
Measured: Week 48
Secondary outcomes (2)
Time to Recurrence
Time to recurrence during the 48-week study period
Measured: until confirmed tumour recurrence, or for a maximum of 48 weeks
Survival Rate
Survival rate at the end of the 48-week study period
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellxpert Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Responsible party
- Sponsor
- Investigators
- Pei-Jer Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247728
- Sponsor's protocol ID
- MG 002
- Other IDs
- PR88204
- Status last verified
- Jun 2022
- First submitted
- 1 Nov 2005
- Last updated
- 23 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 25170226Liu 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.
PubMed 19303160
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
- ClinicalTrials.gov ID
- NCT00247728
- Acronym / sponsor ID
- MG 002
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- PI-88, post resection hepatoma, adjuvant therapy, hepatectomy, hepatoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Cellxpert Biotechnology Corp.Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Study start
- Jun 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Untreated Control | No intervention | –Untreated control arm |
| 160 mg PI-88/Day | Experimental | Drug: PI-88PI-88 160 mg/day SC injection |
| 250 mg PI-88/Day | Experimental | Drug: PI-88PI-88 250 mg/day SC injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PI-88Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks | Drug | 160 mg PI-88/Day, 250 mg PI-88/Day |
Primary outcome
Tumour Non-recurrence Rate
Time frame: Week 48
The tumor non-recurrence rate at the end of the 48-week study period
2 secondary outcomes
Time to Recurrence
Time frame: until confirmed tumour recurrence, or for a maximum of 48 weeks
Survival Rate
Time frame: Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25170226Liu 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.
- Derived from this study: PubMed 19303160Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Jer Chen, MD, PhD principal investigator
National Taiwan University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PI-88 in people with Carcinoma, Hepatocellular, run by Cellxpert Biotechnology Corp. at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour Non-recurrence Rate (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247728, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.