Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

NCT ID: NCT02006030

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-15
• Study Completion Date: 2017-11-01

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.

Conditions

Unresectable Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADI-PEG 20 + TACE

ADI-PEG 20 plus concurrent transarterial chemoembolization

Group Type: EXPERIMENTAL

ADI-PEG 20

Intervention Type: DRUG

Transarterial chemoembolization

Intervention Type: DRUG

Transarterial chemoembolization (TACE)

transarterial chemoembolization alone

Group Type: ACTIVE_COMPARATOR

Transarterial chemoembolization

Intervention Type: DRUG

Interventions

ADI-PEG 20

Intervention Type: DRUG

Transarterial chemoembolization

Intervention Type: DRUG

Other Intervention Names

arginine deiminase formulated with polyethylene glycol; TACE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polaris Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Jer Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Taipei, Taiwan

Locations

CMUH

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

TP-VGH

Taipei, , Taiwan

CGMH-LK

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

POLARIS2013-003

Identifier Type: -

Identifier Source: org_study_id