Unresectable Hepatocellular CarcinomaPhase 2TACENCT02006030
Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing ADI-PEG 20 and Transarterial chemoembolization in people with Unresectable Hepatocellular Carcinoma, run by Polaris Group at 4 sites in Taiwan.
Trial summary
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- ADI-PEG 20 and Transarterial chemoembolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesTaiwan
- Study dates
- 15 Oct 2014to 1 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of HCC confirmed clinically or histologically or cytologically. A clinical diagnosis of HCC, using the 2010 Guideline of the American Association for the Study of Liver Diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, CT or MRI) compatible with HCC, and no evidence of other gastrointestinal tumors (Bruix [2011] - Guideline, 2010).
- Solitary hepatic tumor <8 cm in diameter or multifocal disease as evidenced by CT or MRI scan. Tumor volume ≥50% of liver organ or infiltrating HCC should be excluded.
- Not a candidate for surgical resection or ablation of the tumor.
- The target lesion must not have been treated previously with local therapy, including TACE. Prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable.
- The subject must have received no more than 2 TACE (n≤ 2) or the previous TACE was performed longer than 2 months before enrollment.
- Local therapy must have been completed at least 4 weeks before baseline scan.
- Measurable disease using mRECIST criteria (Appendix A) and RECIST1.1 (Appendix B) criteria. At least 1 measurable lesion must be present.
- Barcelona Clinic Liver Cancer (BCLC) staging classification B (intermediate stage) (Appendix C).
Who cannot join
- 1. Candidate for potential curative therapies (i.e., resection or transplantation).
- Prior allograft transplantation including liver transplantation.
- Significant cardiac disease (New York Heart Association Class III or IV; Appendix F).
- Serious infection requiring treatment with systemically administered antibiotics.
- Pregnancy or lactation.
- Expected non-compliance.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
- Subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
CMUH
Taichung
National Taiwan University Hospital
Taipei
TP-VGH
Taipei
CGMH-LK
Taoyuan
About this study
Official title: Randomized, Open Label, Phase 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- ADI-PEG 20, Transarterial chemoembolization
- Keywords
- Unresectable Hepatocellular Carcinoma, Liver Cancer, ADI, ADI-PEG 20
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-PEG 20Drug
Also called arginine deiminase formulated with polyethylene glycol
Transarterial chemoembolizationDrug
Also called TACE
| Study group | Role | What they receive |
|---|---|---|
| ADI-PEG 20 + TACE | Experimental | ADI-PEG 20 plus concurrent transarterial chemoembolization Receives: Drug: ADI-PEG 20; Drug: Transarterial chemoembolization |
| Transarterial chemoembolization (TACE) | Active comparator | transarterial chemoembolization alone Receives: Drug: Transarterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine time to tumor progression (TTP)
Measured: 2 years estimated - course of study
Secondary outcomes (1)
Tumor response rates
Measured: 2 years estimated - course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study start15 Oct 2014
- Primary completion31 Jul 2016
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei-Jer Chen, MD, PhD, Principal investigator, National Taiwan University Hospital Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006030
- Sponsor's protocol ID
- POLARIS2013-003
- Acronym
- TACE
- Status last verified
- Sep 2016
- First submitted
- 27 Nov 2013
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Phase 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02006030
- Acronym / sponsor ID
- TACE / POLARIS2013-003
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Unresectable Hepatocellular Carcinoma, Liver Cancer, ADI, ADI-PEG 20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADI-PEG 20 + TACE | Experimental | Drug: ADI-PEG 20, Drug: Transarterial chemoembolizationADI-PEG 20 plus concurrent transarterial chemoembolization |
| Transarterial chemoembolization (TACE) | Active comparator | Drug: Transarterial chemoembolizationtransarterial chemoembolization alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of HCC confirmed clinically or histologically or cytologically. A clinical diagnosis of HCC, using the 2010 Guideline of the American Association for the Study of Liver Diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, CT or MRI) compatible with HCC, and no evidence of other gastrointestinal tumors (Bruix [2011] - Guideline, 2010).
- Solitary hepatic tumor <8 cm in diameter or multifocal disease as evidenced by CT or MRI scan. Tumor volume ≥50% of liver organ or infiltrating HCC should be excluded.
- Not a candidate for surgical resection or ablation of the tumor.
- The target lesion must not have been treated previously with local therapy, including TACE. Prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable.
- The subject must have received no more than 2 TACE (n≤ 2) or the previous TACE was performed longer than 2 months before enrollment.
Key exclusion criteria (8 listed)
- 1. Candidate for potential curative therapies (i.e., resection or transplantation).
- Prior allograft transplantation including liver transplantation.
- Significant cardiac disease (New York Heart Association Class III or IV; Appendix F).
- Serious infection requiring treatment with systemically administered antibiotics.
- Pregnancy or lactation.
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 |
|---|---|---|
| ADI-PEG 20Also: arginine deiminase formulated with polyethylene glycol | Drug | ADI-PEG 20 + TACE |
| Transarterial chemoembolizationAlso: TACE | Drug | ADI-PEG 20 + TACE, Transarterial chemoembolization (TACE) |
Primary outcome
Determine time to tumor progression (TTP)
Time frame: 2 years estimated - course of study
1 secondary outcome
Tumor response rates
Time frame: 2 years estimated - course of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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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 Taipei, Taiwan
4 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 ADI-PEG 20 and Transarterial chemoembolization in people with Unresectable Hepatocellular Carcinoma, run by Polaris Group at 4 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 8 inclusion and 8 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine time to tumor progression (TTP) (time frame: 2 years estimated - course of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2018.