OncoMatch/Clinical Trials/NCT05317819
Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
Is NCT05317819 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies ADI-PEG20 for hepatocellular carcinoma.
Treatment: ADI-PEG20 — Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic agent — for Child-Pugh A subjects
Prior treatment with at least 1 systemic agent for Child-Pugh A subjects.
Cannot have received: ADI-PEG 20 (ADI-PEG 20)
Subjects who had been treated with ADI-PEG 20 previously.
Cannot have received: allograft transplantation
Prior allograft transplantation including liver transplantation.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >1,500/µL; Platelets >50,000/µL
Kidney function
Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL/min.
Liver function
Total bilirubin < 3.0 mg/dL and no evidence of bile obstruction; ALT and AST ≤5 x upper limit of normal range; serum albumin level ≥ 3.0 g/dl; PT <3 seconds above control or INR <1.7
Total bilirubin < 3.0 mg/dL and no evidence of bile obstruction. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range. Serum albumin level ≥ 3.0 g/dl. Prothrombin time (PT)-international normalized ratio (INR): PT <3 seconds above control or INR <1.7. Absolute neutrophil count (ANC) >1,500/µL. Platelets >50,000/µL. Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify