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 read and understood the possible risks and benefits of the trial and have signed a consent form agreeing to take part.
• People aged between 18 and 75 years old (including those aged exactly 18 or 75).
• People with advanced liver cancer (hepatocellular carcinoma) that has been confirmed by laboratory testing of tissue or cell samples to carry a protein called GPC3. The cancer must be at an advanced stage — either no longer responding to, or not suitable for, local treatments such as ablation, interventional procedures, or radiotherapy — and must have already been treated with at least one standard systemic treatment (such as chemotherapy or targeted therapy) that either stopped working or could not be tolerated.
• People whose tumour tissue sample, tested using a specific laboratory method (immunohistochemistry), shows that more than 25% of the cancer cells carry the GPC3 protein at a measurable level.
• People whose liver function score (Child-Pugh score) is 7 or below, indicating acceptable liver function.
• People who have at least one tumour that can be measured and tracked using standard imaging criteria (RECIST 1.1).
• People whose general physical ability level is rated 0, 1, or 2 on a standard scale used in cancer care (ECOG performance status), meaning they are able to carry out at least some daily activities.
• People who are expected to live for at least 3 months.
• People whose blood counts meet specific minimum levels — including white blood cells, lymphocytes, platelets, and haemoglobin — without having received blood-boosting treatments or transfusions in the 3 days before testing (confirm specific values with trial site).
• People whose blood chemistry results — including liver enzymes, bilirubin, albumin, and kidney function markers — fall within the ranges set by the trial (confirm specific values with trial site).
• People whose blood clotting test results fall within the ranges set by the trial (confirm specific values with trial site).
• People who, if they test positive for a hepatitis B marker (HBsAg or HBcAb), have a hepatitis B virus level at or below 2,000 IU/mL.
• People of childbearing potential who have a negative blood pregnancy test at the required timepoints during the trial process, and who agree to use effective contraception during the study and for at least 1 year after completing treatment — this requirement also applies to their partners.

Who may not be able to join:

• People who have had a second type of cancer, unless they received treatment aimed at curing it and have been cancer-free for at least 5 years. Some lower-risk cancer types, such as certain skin cancers, early-stage cervical changes, or prostate cancer under active monitoring, may be considered differently (confirm with trial site).
• People who have previously received a type of immune cell therapy called CAR-T or TCR-T therapy, a therapeutic cancer vaccine, or any treatment that specifically targeted the GPC3 protein.
• People who received certain anti-cancer treatments within specific timeframes before the blood collection procedure (apheresis) — including chemotherapy within 14 days, targeted or experimental drug therapies within 14 days or 5 half-lives (whichever is longer), antibody therapies within 21 days, immune-modulating therapies within 7 days, or radiotherapy within 14 days.
• People whose side effects from previous cancer treatments have not improved to a mild level or resolved, with the exception of hair loss, mild nerve-related symptoms in the hands or feet, or an underactive thyroid managed with medication.
• People who have had an organ transplant in the past or are currently on a waiting list for one, including liver transplant.
• People who have cancer that has spread to the brain and is causing neurological symptoms, or who have other significant brain or nervous system conditions.
• People who have a history of a condition called hepatic encephalopathy (a brain condition caused by liver failure), or who currently have it.
• People who have fluid build-up in the abdomen (ascites) that requires medical treatment to manage.
• People whose liver cancer takes up 50% or more of the healthy liver tissue as seen on imaging, or who have a blood clot caused by the tumour in a major blood vessel near the liver.
• People who are pregnant or currently breastfeeding.
• People who test positive for hepatitis C antibodies with detectable virus levels, or who test positive for HIV, or who have active syphilis. Note: people who test positive for hepatitis C antibodies but have no detectable hepatitis C virus may still be considered.
• People with serious underlying health conditions, including: active serious infections; active or unstable autoimmune diseases or a history of autoimmune disease within the past 3 years; uncontrolled diabetes; significant heart failure or reduced heart pumping function; a heart attack or unstable chest pain within the past 6 months; high blood pressure that cannot be brought under control even with two medications; certain serious heart rhythm problems or other heart conditions judged unsuitable by the trial doctor; or significant, poorly controlled mental health conditions or dementia.
• People who have had a stroke or seizure within the 6 months before signing the consent form.
• People with a significant tendency to bleed, such as active bleeding in the digestive system or a blood clotting disorder.
• People who require long-term use of corticosteroid medications (such as prednisone) or other medicines that suppress the immune system, or who have taken high-dose corticosteroids or immune-suppressing drugs within 7 days before the blood collection procedure. Short-term or localised use of corticosteroids (for example, skin creams, eye drops, nasal sprays, or a brief course to prevent a reaction to contrast dye) may be acceptable (confirm with trial site).
• People who received a live vaccine within 4 weeks before the blood collection procedure.
• People who had major surgery within 2 weeks before the blood collection procedure, or who are planning to have major surgery during the trial. Minor procedures done under local anaesthetic may be acceptable (confirm with trial site).
• People with a history of severe allergic reactions, or known sensitivity to any of the drugs or ingredients used in this trial.
• People whom the trial doctor considers unsuitable for participation for any other reason.

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