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

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

Trial Details

NCT ID
NCT05317819
Phase
PHASE3
Sponsor
Polaris Group
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • ADI-PEG20
  • Placebo
Locations (sample)
  • Changhua, Taiwan|24.0692,120.5512
  • Chiayi City, Taiwan|23.47917,120.44889
  • Chiayi City, Taiwan|23.47917,120.44889
  • Kaohsiung City, Taiwan|22.61626,120.31333
  • Kaohsiung City, Taiwan|22.61626,120.31333

Key Eligibility Criteria

  • Prior diagnosis of HCC confirmed by radiology, histology, or cytology.
  • Prior treatment with at least 1 systemic agent for Child-Pugh A subjects. However, Child-Pugh B7 subjects without prior systemic treatment may be e…
  • Plasma arginine ≥ 78 μM at pre-screening visit.
  • Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapies…

For full eligibility, visit ClinicalTrials.gov.

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