NCT02006030

Brief 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. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Typical duration for phase_2

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

November 27, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

October 15, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

September 4, 2018

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

November 27, 2013

Last Update Submit

August 30, 2018

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Unresectable Hepatocellular CarcinomaLiver CancerADIADI-PEG 20

Outcome Measures

Primary Outcomes (1)

  • Determine time to tumor progression (TTP)

    2 years estimated - course of study

Secondary Outcomes (1)

  • Tumor response rates

    2 years estimated - course of study

Study Arms (2)

ADI-PEG 20 + TACE

EXPERIMENTAL

ADI-PEG 20 plus concurrent transarterial chemoembolization

Drug: ADI-PEG 20Drug: Transarterial chemoembolization

Transarterial chemoembolization (TACE)

ACTIVE COMPARATOR

transarterial chemoembolization alone

Drug: Transarterial chemoembolization

Interventions

ADI-PEG 20DRUG
Also known as: arginine deiminase formulated with polyethylene glycol
ADI-PEG 20 + TACE
Transarterial chemoembolizationDRUG
Also known as: TACE
ADI-PEG 20 + TACETransarterial chemoembolization (TACE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CMUH

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

TP-VGH

Taipei, Taiwan

Location

CGMH-LK

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

ADI PEG20Polyethylene Glycols

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Pei-Jer Chen, MD, PhD

    National Taiwan University Hospital Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

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 27, 2013

First Posted

December 9, 2013

Study Start

October 15, 2014

Primary Completion

July 31, 2016

Study Completion

November 1, 2017

Last Updated

September 4, 2018

Record last verified: 2016-09

Locations

TW(4)