RecruitingPhase 3NCT05317819

Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma

A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma


Sponsor

Polaris Group

Enrollment

300 participants

Start Date

Mar 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests ADI-PEG 20 — a drug that depletes arginine, an amino acid that some liver cancers depend on to survive — in patients with unresectable liver cancer (hepatocellular carcinoma, or HCC) who have elevated arginine levels in their blood. The idea is that starving the tumor of arginine may slow its growth. **You may be eligible if...** - You have a confirmed diagnosis of HCC (by imaging, biopsy, or cytology) - Your cancer cannot be surgically removed - Your blood arginine level is 78 μM or higher (measured at a pre-screening visit) - You have at least one measurable tumor - You have received prior treatment with at least one systemic therapy (for Child-Pugh A patients); Child-Pugh B7 patients with no prior systemic treatment may be eligible if approved therapies are not accessible **You may NOT be eligible if...** - Your arginine levels are below the required threshold - You have severe liver dysfunction (Child-Pugh C) - You have had recent major surgery or active serious infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGADI-PEG20

Treatment for hepatocellular carcinoma

OTHERPlacebo

Treatment for hepatocellular carcinoma


Locations(11)

Changhua Christian Hospital (CCH)

Changhua, Taiwan

Ditmanson Medical Foundation Chiayi Christian Hospital (CYCH)

Chiayi City, Taiwan

Chang Gung Medical Foundation-Chia-Yi (CGMF-CY)

Chiayi City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, Taiwan

Chang Gung Medical Foundation-Kaohsiung(CGMF-KS)

Kaohsiung City, Taiwan

Chi Mei Medical Center (CMMC-YK)

Tainan, Taiwan

Chi Mei Hospital, Liouying (CMMC-LY)

Tainan, Taiwan

Chang Gung Medical Foundation-Linkou (CGMF-LK)

Taoyuan, Taiwan

Bach Mai Hospital

Hanoi, Vietnam

K Hospital

Hà Nội, Vietnam

Hue Central Hospital

Huế, Vietnam

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05317819


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