This trial is active, not recruiting.

Condition unresectable hepatocellular carcinoma
Treatment adi-peg 20
Phase phase 2
Sponsor Polaris Group
Start date June 2014
End date November 2016
Trial size 40 participants
Trial identifier NCT02006030, POLARIS2013-003


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
arginine deiminase formulated with polyethylene glycol
adi-peg 20

Primary Outcomes

Determine time to tumor progression (TTP)
time frame: 2 years estimated - course of study

Secondary Outcomes

Tumor response rates
time frame: 2 years estimated - course of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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). 2. 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. 3. Not a candidate for surgical resection or ablation of the tumor. 4. 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. 5. The subject must have received no more than 2 TACE (n≤ 2) or the previous TACE was performed longer than 2 months before enrollment. 6. Local therapy must have been completed at least 4 weeks before baseline scan. 7. Measurable disease using mRECIST criteria (Appendix A) and RECIST1.1 (Appendix B) criteria. At least 1 measurable lesion must be present. 8. Barcelona Clinic Liver Cancer (BCLC) staging classification B (intermediate stage) (Appendix C). Exclusion Criteria: 1. 1. Candidate for potential curative therapies (i.e., resection or transplantation). 2. Prior allograft transplantation including liver transplantation. 3. Significant cardiac disease (New York Heart Association Class III or IV; Appendix F). 4. Serious infection requiring treatment with systemically administered antibiotics. 5. Pregnancy or lactation. 6. Expected non-compliance. 7. 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. 8. Subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.

Additional Information

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
Principal investigator Pei-Jer Chen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Polaris Group.