Clinical trial NCT02006030: Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: Unresectable Hepatocellular Carcinoma
Liver Cancer
ADI
ADI-PEG 20
Lead sponsor: Polaris Group
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Determine time to tumor progression (TTP)
timeFrame: 2 years estimated - course of study
Secondary outcomes:
measure: Tumor response rates
timeFrame: 2 years estimated - course of study
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: CMUH
city: Taipei City
country: Taiwan
facility: TP-VGH
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: CGMH-LK
Study officials:
affiliation: National Taiwan University Hospital Taipei, Taiwan
name: Pei-Jer Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: