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Clinical Trials List

Protocol NumberPOLARIS2021-001
NCT Number(ClinicalTrials.gov Identfier)NCT05317819
Active

2022-02-16 - 2026-12-31

Others

Recruiting9

A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With Genotype WWOX-GG, Unresectable Hepatocellular Carcinoma

  • Trial Applicant

  • Sponsor

    Polaris Group

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張德生 Digestive System Department
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Lung Yu Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 周莒光 醫師 Digestive System Department
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳鴻昌 醫師 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Wen Chen Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 徐友春 醫師 Digestive System Department
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen-Chun Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma Advanced Hepatocellular Carcinoma

Objectives

Primary Outcome : Overall Survival (OS) Secondary Outcome : Progression free survival

Test Drug

ADI-PEG 20

Active Ingredient

Arginine deiminase conjugated to polyethylene glycol 20,000 mw

Dosage Form

Injection

Dosage

3.5ml/vial；11.5±1.0mg/ml

Endpoints

Primary Outcome :
Overall Survival (OS)
Secondary Outcome :
Progression free survival

Inclution 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 enrolled, if they are not eligible for any approved systemic therapies.
WWOX genotype GG.
Measurable disease using RECIST 1.1. At least 1 measurable lesion must be present.
Child-Pugh (cirrhosis status) score class A-B7.
Barcelona Cancer of the Liver (BCLC) stage C.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
Expected survival of at least 3 months.
Age >20 years.
Fully recovered from prior surgery, radiation, or chemotherapy, and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed.
Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study and for 35 days after last dose of ADI-PEG 20. Male partners of female subjects and female partners of male subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study if they are of childbearing potential. Females of childbearing potential must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this subject is deemed eligible. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual period for at least 12 months).
Informed consent must be obtained prior to study initiation.
No concurrent investigational studies are allowed.
Total bilirubin < 3.0 mg/dL and no evidence of bile obstruction.
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range.
Serum albumin level ≥ 3.0 g/dl.
Prothrombin time (PT)-international normalized ratio (INR): PT <3 seconds above control or INR <1.7.
Absolute neutrophil count (ANC) >1,500/μL.
Platelets >50,000/μL.
Serum uric acid ≤ 8 mg/dL (with or without medication control).
Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL/min.
Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon.
Encephalopathy - none or mild (grade 1 or 2, by Child-Pugh classification); lactulose of other supportive care allowed.
Ascites - absent or slight (by Child-Pugh classification); diuretic therapy allowed

Exclusion Criteria

Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs.
Prior allograft transplantation including liver transplantation.
Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia.
Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
Pregnancy or lactation.
Expected non-compliance.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.
Subjects who had been treated with ADI-PEG 20 previously.
History of uncontrolled seizure disorder not related to underlying cancer.
Allergy to pegylated compounds.
Allergy to E. coli drug products (such as GMCSF).
Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.
Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until week 1 visit.
Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

The Estimated Number of Participants

  • Taiwan

    200 participants

  • Global

    300 participants

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