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 (Jun 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
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT05317819 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ADI-PEG 20, allograft transplantation disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 99 years or younger.
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 qualifyRelated pages