Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma
Trial Parameters
Brief Summary
To compare the clinical outcomes of Lenvatinib treatment alone or Lenvatinib + ADI-PEG20 combination treatment in advanced HCC patients with BCLC stage C.
Eligibility Criteria
Inclusion Criteria: 1. Prior diagnosis of HCC confirmed by radiology, histology, or cytology. 2. Patients were rs-6025211 non-TT with rs9679162 non-GG genotype , or serum arginine level ≥ 84.2 µM with rs9679162 non-GG genotype. Treatment naïve or under Lenvatinib treatment for \< 2 months. 3. Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. 4. Child-Pugh (cirrhosis status) score class A (Appendix C). 5. Barcelona Cancer of the Liver (BCLC) stage C (Appendix B). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment (Appendix D). 7. Expected survival of at least 3 months. 8. Age \>18 years. 9. Fully recovered from prior surgery and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed. 10. Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Male partners of female subjects and female par