Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
NCT05317819 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-12-18
Summary
Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
Conditions
Interventions
- DRUG
-
ADI-PEG20
Treatment for hepatocellular carcinoma
- OTHER
-
Placebo
Treatment for hepatocellular carcinoma
Sponsors & Collaborators
-
Polaris Group
lead INDUSTRY
Principal Investigators
-
John S Bomalaski · Polaris Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-14
- Primary Completion
- 2028-09-30
- Completion
- 2028-12-31
Countries
- Taiwan
- Vietnam
Study Locations
More Related Trials
-
Novel Treatment of Advanced Hepatocellular Carcinoma
NCT03950518 ·Status: UNKNOWN ·Phase: PHASE3
-
Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation
NCT06248554 ·Status: RECRUITING ·Phase: NA
-
A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)
NCT02029157 ·Status: COMPLETED ·Phase: PHASE3
-
Treatment of Advanced Hepatocellular Carcinoma
NCT03278444 ·Status: UNKNOWN ·Phase: PHASE3
-
Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma
NCT05609695 ·Status: UNKNOWN
-
Testing of ADI-PEG in Hepatocellular Carcinoma
NCT00056992 ·Status: COMPLETED ·Phase: PHASE2
-
Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer
NCT04965714 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Trial of Hepatic Arterial Infusion Combined With Bevacizumab and Sintilimab for Unresectable A-staged Hepatocellular Carcinoma in BCLC Classification (D-TRIPLET)
NCT05214339 ·Status: UNKNOWN ·Phase: PHASE2
-
Anti-PD-1/PD-L1 Antibodies Plus Pegylated Interferon Alfa-2b Treatment in Patients With Advanced-Stage HCC
NCT04943679 ·Status: UNKNOWN
-
Anti-angiogenic Agents Plus Anti-PD-1 Antibodies for uHCC
NCT04639284 ·Status: UNKNOWN
-
Ablation Combined With PD-1 in HCC: Phase II Study
NCT04652440 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy
NCT01755767 ·Status: COMPLETED ·Phase: PHASE3
-
Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
NCT05383066 ·Status: UNKNOWN
-
Study of Pegylated Human Recombinant Arginase for Liver Cancer
NCT00988195 ·Status: COMPLETED ·Phase: PHASE1
-
Systemic Chemotherapy Plus Lenvatinib and Toripalimab for HCC With Extrahepatic Metastasis
NCT04170179 ·Status: UNKNOWN ·Phase: PHASE2
-
Anti-PD-1/PD-L1 Antibodies Plus Anti-VEGF Antibody Treatment in Patients With Advanced-Stage HCC
NCT06537908 ·Status: RECRUITING
-
Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection
NCT03990974 ·Status: SUSPENDED ·Phase: PHASE3
-
Adjuvant Therapy With Apatinib for HCC Patients With PVTT Who Underwent Radical Resection
NCT03261791 ·Status: UNKNOWN ·Phase: PHASE2
-
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
NCT03586050 ·Status: COMPLETED ·Phase: NA
-
RT+ Anti-PD-1 for Patients With Advanced HCC (RT+PD-1-HCC)
NCT04193696 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients
NCT05281926 ·Status: UNKNOWN ·Phase: PHASE1
-
Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC
NCT02967887 ·Status: UNKNOWN ·Phase: PHASE2
-
A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion
NCT03971201 ·Status: UNKNOWN ·Phase: PHASE2
-
Effects of Antiviral Therapy on Patients With HBV-related HCC
NCT05406089 ·Status: COMPLETED
-
Antiviral Therapy for Patients With Liver Cancer After Surgery
NCT05466565 ·Status: RECRUITING