NCT05317819

Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma

A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC

Detailed description

Safety will be evaluated by laboratory tests, vital sign measurements, physical examinations and subject medical history which will be performed to detect new abnormalities and any deterioration in pre-existing conditions. Efficacy will be determined by overall survival, progression free survival, pharmacodynamics (peripheral blood arginine and citrulline levels) and immunogenicity (antibodies to ADI-PEG 20).

Conditions

• Hepatocellular Carcinoma
• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	ADI-PEG20	Treatment for hepatocellular carcinoma
OTHER	Placebo	Treatment for hepatocellular carcinoma

Timeline

• Start date: 2022-03-14
• Primary completion: 2028-09-01
• Completion: 2028-12-01
• First posted: 2022-04-08
• Last updated: 2025-12-18

Locations

11 sites across 2 countries: Taiwan, Vietnam