Phase 2 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, or HCC), confirmed by imaging scans, tissue sample, or cell sample.
• People who meet specific genetic and/or blood test results — specifically, those with a certain combination of genetic markers (rs-6025211 non-TT with rs9679162 non-GG), or a blood arginine level of 84.2 µM or above with rs9679162 non-GG genetic marker (confirm with trial site for what this means for a specific case).
• People who are either new to treatment for liver cancer, or who have been on the drug Lenvatinib for less than 2 months.
• People who have at least one measurable liver cancer tumour, as measured by standard imaging methods.
• People whose liver function is rated as Child-Pugh class A (a measure of how well the liver is working).
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage C, which is an advanced stage of the disease.
• People who are reasonably active and able to care for themselves, rated 0 or 1 on the ECOG performance scale (confirm with trial site for details).
• People with an expected survival of at least 3 months.
• People aged over 18 years.
• People who have fully recovered from any prior surgery, and have not had surgery within 2 weeks before the first study visit (a liver biopsy for diagnosis is allowed).
• People who agree to use appropriate contraception throughout the study, as required by the trial.
• Women of childbearing age who have a negative pregnancy blood test before entering the trial.
• Women who are not of childbearing age, defined as having had no menstrual period for at least 12 months.
• People who have given written informed consent before the study begins.
• People who are not participating in any other clinical trial at the same time.
• People whose blood test results fall within the ranges required by the trial, including liver enzymes, bilirubin, albumin, blood clotting, blood cell counts, uric acid, and kidney function (confirm with trial site for specific values).
• People with active hepatitis B or C who are on antiviral medication (other than interferon) may be able to remain on that treatment.
• People with no or only mild liver-related brain symptoms (encephalopathy grade 1 or 2), with or without supportive medication.
• People with no or only slight fluid build-up in the abdomen (ascites), with or without diuretic medication.

Who may not be able to join:

• People who are considered suitable candidates for potentially curative treatments such as surgery or liver transplant, or whose doctors determine them eligible for approved systemic drug therapies.
• People who have previously had an 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).
• People who have a serious infection requiring antibiotics given through a drip or injection at the time of enrolment, or who have needed such treatment in the 7 days before starting the trial.
• People who are pregnant or breastfeeding.
• People who are not expected to be able to follow the trial requirements reliably.
• People with uncontrolled ongoing illness, including serious heart conditions (heart failure class III or IV), irregular heart rhythms, uncontrolled infection, or psychiatric or social conditions that would make it difficult to follow the study requirements.
• People with a history of another primary cancer, unless it was: skin cancer (non-melanoma) that was fully removed; cervical cancer in situ that was fully treated; or another solid tumour with no known active disease that the trial doctor does not expect to affect the person's outcome.
• People who have previously been treated with the study drug ADI-PEG 20.
• People with a history of uncontrolled seizures not related to their cancer.
• People who are known to be HIV positive, or who have active hepatitis B or active hepatitis C with elevated liver enzymes above five times the normal limit.
• People who are allergic to pegylated compounds (a type of chemical modification used in some drugs).
• People who are allergic to products derived from E. coli bacteria (such as certain growth factor medications).
• People who have had bleeding from oesophageal or stomach varices (enlarged veins) in the past three months, unless the varices have been treated or banded.
• People with uncontrolled fluid build-up in the abdomen (ascites) that does not respond well to diuretic medication.
• People who have received blood transfusions, blood products, erythropoietin, albumin, or certain blood cell growth factors within 7 days before or after screening blood tests, up until the first study visit.
• People who have used traditional medicines approved by local authorities — including Chinese herbal medicines — within 2 weeks before the first study visit.
• People rated 2 or above on the ECOG performance scale, meaning those who are more limited in daily activity.

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