Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
Trial Parameters
Brief Summary
Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
Eligibility Criteria
Inclusion Criteria: 1. Prior diagnosis of HCC confirmed by radiology, histology, or cytology. 2. Prior treatment with at least 1 systemic agent for Child-Pugh A subjects. However, Child-Pugh B7 subjects without prior systemic treatment may be enrolled, if they are not eligible for any approved systemic therapies (e.g., due to financial factors). 3. Plasma arginine ≥ 78 μM at pre-screening visit. 4. Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapies are eligible, provided that they have either a target lesion which has not been treated with local therapy and/or the target lesion(s) within the field of the local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. 5. Child-Pugh (cirrhosis status) score class A-B7 (Appendix C). 6. Barcelona Cancer of the Liver (BCLC) stage C (Appendix B) 7. Eastern Coo