Actively Recruiting
Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
Led by Polaris Group · Updated on 2025-12-18
300
Participants Needed
11
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
CONDITIONS
Official Title
Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
- Prior treatment with at least one systemic agent for Child-Pugh A subjects; Child-Pugh B7 subjects without prior systemic treatment may enroll if ineligible for approved therapies
- Plasma arginine level of at least 78 micromoles per liter at pre-screening
- Presence of at least one measurable lesion by RECIST 1.1 criteria
- Completion of local-regional therapy at least 4 weeks before baseline CT scan if applicable
- Child-Pugh class A or B7 liver function
- Barcelona Cancer of the Liver (BCLC) stage C
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 3 months
- Age over 18 years
- Full recovery from prior surgery, radiation, or chemotherapy with none within 2 weeks before week 1 visit
- Female and male participants must agree to use effective contraception during the study and for 35 days after last dose
- Negative pregnancy test for females of childbearing potential before study entry
- Post-menopausal status for females not of childbearing potential
- Signed informed consent prior to study start
- No participation in other investigational studies
- Total bilirubin under 3.0 mg/dL without bile obstruction
- Serum ALT and AST less than or equal to 5 times the upper limit of normal
- Serum albumin at least 3.0 g/dL
- Prothrombin time less than 3 seconds above control or INR under 1.7
- Absolute neutrophil count above 1,500/μL
- Platelet count above 50,000/μL
- Serum uric acid 8 mg/dL or lower
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 40 mL/min if higher
- Stable treatment for active hepatitis B or C allowed except interferon
- No or mild encephalopathy (grade 1 or 2); lactulose or supportive care allowed
- Absent or slight ascites; diuretic therapy allowed
You will not qualify if you...
- Eligible for curative therapies such as resection or transplantation or approved systemic therapies
- Prior liver or other allograft transplantation
- Not fully recovered from previous HCC treatments except for mild alopecia
- Serious infection requiring intravenous or systemic antibiotics at study entry or within 7 days prior
- Pregnancy or breastfeeding
- Likely non-compliance with study procedures
- Uncontrolled illnesses such as active infections, severe heart failure, arrhythmias, psychiatric illnesses, or social conditions limiting compliance
- History of another active primary cancer except certain treated skin or cervical cancers or inactive solid tumors
- Previous treatment with ADI-PEG 20
- Uncontrolled seizure disorders unrelated to cancer
- Allergy to pegylated compounds or E. coli derived products
- Bleeding esophageal or gastric varices in past 3 months unless treated
- Uncontrolled ascites not responsive to diuretics
- Recent blood transfusions or use of certain blood products within 7 days before screening labs or until week 1
- ECOG performance status 2 or higher
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Changhua Christian Hospital (CCH)
Changhua, Taiwan, 500
Actively Recruiting
2
Ditmanson Medical Foundation Chiayi Christian Hospital (CYCH)
Chiayi City, Taiwan, 600
Actively Recruiting
3
Chang Gung Medical Foundation-Chia-Yi (CGMF-CY)
Chiayi City, Taiwan, 613
Actively Recruiting
4
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Taiwan, 807
Actively Recruiting
5
Chang Gung Medical Foundation-Kaohsiung(CGMF-KS)
Kaohsiung City, Taiwan, 833
Actively Recruiting
6
Chi Mei Medical Center (CMMC-YK)
Tainan, Taiwan, 710
Actively Recruiting
7
Chi Mei Hospital, Liouying (CMMC-LY)
Tainan, Taiwan, 736
Actively Recruiting
8
Chang Gung Medical Foundation-Linkou (CGMF-LK)
Taoyuan, Taiwan, 333
Actively Recruiting
9
Bach Mai Hospital
Hanoi, Vietnam, 100000
Not Yet Recruiting
10
K Hospital
Hà Nội, Vietnam, 100000
Not Yet Recruiting
11
Hue Central Hospital
Huế, Vietnam, 49000
Not Yet Recruiting
Research Team
M
Maureen Liu
CONTACT
D
Doris Cheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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