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
- 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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