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

NCT05317819 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-18

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

ADI-PEG20

Treatment for hepatocellular carcinoma

OTHER

Placebo

Treatment for hepatocellular carcinoma

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Principal Investigators

  • John S Bomalaski · Polaris Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • Taiwan
  • Vietnam

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317819 on ClinicalTrials.gov