Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
NCT02006030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2018-09-04
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
Interventions
- DRUG
-
ADI-PEG 20
- DRUG
-
Transarterial chemoembolization
Sponsors & Collaborators
-
Polaris Group
lead INDUSTRY
Principal Investigators
-
Pei-Jer Chen, MD, PhD · National Taiwan University Hospital Taipei, Taiwan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-15
- Primary Completion
- 2016-07-31
- Completion
- 2017-11-01
Countries
- Taiwan
Study Locations
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