Phase 3 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with liver cancer (hepatocellular carcinoma/HCC), confirmed by imaging or tissue testing.
• People who have already received at least one whole-body (systemic) treatment for liver cancer — or, for those with a specific liver function score (Child-Pugh B7), people who have not had prior systemic treatment but are not eligible for any currently approved systemic therapies (for example, due to financial reasons).
• People whose blood arginine level is at or above a certain threshold (78 μM), measured at a pre-screening visit.
• People who have at least one measurable area of cancer that can be tracked on scans, using a standard measurement system (RECIST 1.1). People who have had local treatments to the liver may still be eligible, provided that either an untreated area of cancer can be measured, or a previously treated area has grown by at least 20% in size — and the local treatment was completed at least 4 weeks before the baseline scan.
• People with a liver function score in the Child-Pugh class A or B7 range.
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage C.
• People with a general health/activity score (ECOG performance status) of 0 or 1 at the time of enrolment, meaning they are fully active or have only minor limitations on physical activity.
• People who are expected to live for at least 3 more months.
• People aged over 18 years.
• People who have fully recovered from any prior surgery, radiation, or chemotherapy, and have not had any of these treatments within the 2 weeks before the first study visit. A liver biopsy to confirm the cancer diagnosis is permitted.
• People who are willing and able to use appropriate contraception during the study and for 35 days after the last dose of the study treatment. This applies to both male and female participants, as well as their partners if those partners are capable of becoming pregnant. Female participants capable of becoming pregnant must have a negative pregnancy blood test before entering the study. Female participants who are not capable of becoming pregnant must have had no regular menstrual periods for at least 12 months (post-menopausal).
• People who have provided written informed consent before any study activities begin.
• People who are not taking part in any other research study at the same time.
• People whose liver-related blood test results fall within acceptable ranges, specifically: total bilirubin below 3.0 mg/dL with no bile duct blockage; liver enzyme levels (ALT and AST) no more than 5 times the upper limit of normal; blood albumin at or above 3.0 g/dL; blood clotting results within an acceptable range (PT less than 3 seconds above control, or INR below 1.7); white blood cell count (neutrophils) above 1,500/µL; platelets above 50,000/µL; uric acid at or below 8 mg/dL; and kidney function results within acceptable limits.
• People with active hepatitis B or C who are on antiviral medications may continue those medications, except for interferon.
• People with no brain confusion (encephalopathy) or only mild confusion (grade 1 or 2); supportive medications such as lactulose are permitted.
• People with no fluid build-up in the abdomen (ascites), or only a small amount; diuretic medications to manage this are permitted.

Who may not be able to join:

• People who are considered candidates for potentially curative treatments such as surgical removal of the tumour or a liver transplant, or who are eligible for currently approved systemic therapies based on those drugs' approved uses.
• People who have previously received any organ transplant, including a liver transplant.
• People who have not fully recovered from side effects of previous liver cancer treatments, except for mild hair loss (grade 1).
• People who have a serious infection requiring intravenous antibiotics at the time of enrolment, or who required antibiotic treatment for an infection within 7 days before the first dose of the study treatment.
• People who are pregnant or breastfeeding.
• People who are not expected to be able to follow the study requirements (confirm with trial site).
• People with serious uncontrolled ongoing health conditions, including active infection, severe heart failure (New York Heart Association Class III or IV), irregular heart rhythms, significant psychiatric illness, or personal circumstances that would make it difficult to participate consistently.
• People who have a history of another primary cancer, with the following exceptions: non-melanoma skin cancer that was fully removed; cervical cancer in situ that was fully treated; or another solid tumour with no known active disease, where the investigator considers it unlikely to affect the person's health outcomes.
• People who have previously been treated with the study drug ADI-PEG 20.
• People with a history of seizures that are not controlled and are unrelated to the cancer.
• People with a known allergy to pegylated compounds (a type of chemical coating used in some medications).
• People with a known allergy to drug products derived from E. coli bacteria (such as a medication called GMCSF).
• People who have had bleeding from oesophageal or stomach varices (swollen veins) within the past three months, unless those varices have been treated or banded.
• People with uncontrolled fluid build-up in the abdomen (ascites) that cannot be managed with diuretic medications.
• People who have received a blood transfusion, blood products, erythropoietin, albumin, or certain white blood cell growth factors (G-CSF) within 7 days before screening blood tests, or at any time between screening and the first study visit.
• People with a general health/activity score (ECOG performance status) of 2 or higher, meaning they have significant limitations in daily activities.

Important: Always verify eligibility with the trial site directly before applying.