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 voluntarily agree to take part and sign a consent form (or have a legal guardian sign on their behalf)
• People aged 18 to 75 years old at the time of signing the consent form
• People who have been confirmed by tissue or cell testing to have advanced liver cancer (hepatocellular carcinoma), at a specific advanced stage, without a mixed type involving bile duct cancer, and whose liver function scores within an acceptable range
• People whose tumor has tested positive for a protein called GPC3, as confirmed by a central laboratory test
• People whose liver cancer has gotten worse after, or who could not tolerate, at least two previous standard drug treatments, and who have no other effective treatment options available
• People who have at least one measurable area of cancer that has not been treated with local therapies such as radiation (or, if it was, that area has clearly grown back), and has not been used for a pre-screening biopsy (with specific timing rules if a single lesion required biopsy)
• People who are generally well enough to carry out basic daily activities, rated 0 or 1 on a standard medical performance scale
• People whose doctor estimates they are likely to live at least 12 more weeks
• People whose heart pumping function (measured by an echocardiogram) is at an acceptable level, tested within 28 days before the blood collection procedure
• People whose blood test results meet specific minimum levels for white blood cells, platelets, haemoglobin, liver enzymes, kidney function, bilirubin, albumin, and blood clotting, without recent transfusions or certain blood-boosting medications
• People with a history of or current hepatitis B infection, provided the virus is being well controlled with antiviral medication before the treatment infusion
• People of childbearing potential who test negative for pregnancy, and who agree to use effective contraception for at least 12 months after receiving the treatment (or until the treatment is no longer detectable, whichever comes first)

Who may not be able to join:

• People with a known serious allergy or intolerance to the CAR-T cell product or its ingredients, including a substance called DMSO
• People with known allergies to the chemotherapy drugs used to prepare the body before CAR-T treatment (fludarabine and/or cyclophosphamide)
• People who have had episodes of liver-related confusion (hepatic encephalopathy) in the past 6 months, or who take medications to prevent it
• People with certain brain or nervous system conditions, including epilepsy, severe narrowing of blood vessels in the brain, a stroke within the past 6 months, or significant mental illness
• People with uncontrolled heart or lung conditions, including certain breathing diseases, serious heart rhythm problems, recent heart attack, or heart surgery within the past 6 months
• People who have had an organ transplant, including a liver transplant
• People who have previously received any CAR-T cell therapy, or any treatment specifically targeting the GPC3 protein
• People whose tumour takes up more than half of the total liver tissue
• People who have cancer blocking the main portal vein of the liver (a specific type of blood vessel blockage), seen on imaging before treatment
• People who have had a serious blood clot in a vein or the lungs within the 3 months before the blood collection procedure
• People who have had clinically significant fluid build-up in the abdomen (ascites) requiring drainage procedures within the past 6 months (those who have been on stable fluid-reducing medication for at least 2 months may still be considered)
• People with uncontrolled fluid around the lungs or heart that needs to be drained regularly (once a month or more)
• People with cancer that has spread to the spine or brain, unless it has been treated, is stable, and does not require ongoing steroid medication above a specific dose
• People who have had radiation therapy within 6 weeks of the blood collection procedure, or certain internal radiation treatments within 6 months (or longer, depending on the treatment used)
• People who have had local liver treatments such as surgery, ablation, or chemoembolisation within 4 weeks before the blood collection procedure, or who have wounds that have not yet healed
• People who have received an inactivated or live-weakened vaccine within 4 weeks before the blood collection procedure
• People who have received a blood transfusion within 14 days, or blood cell growth factor support within 21 days, before the blood collection procedure
• People who have recently received certain cancer treatments and have not waited long enough since the last dose before the blood collection procedure (specific waiting periods apply to immunotherapy, chemotherapy, targeted therapy, experimental drugs, steroids, and immune-modifying medications)
• People with a history of another type of cancer, with some exceptions such as certain skin cancers that have been fully removed or early-stage cancers that have been cured
• People with a history of or currently active immune system disorders (such as HIV, lupus, rheumatoid arthritis, or several other named conditions), with some exceptions for minor conditions
• People with active hepatitis C infection (confirmed by both antibody and virus-level testing)
• People known to have both hepatitis B and hepatitis D infections at the same time
• People with a current syphilis infection confirmed by testing
• People with an active infection that requires systemic treatment
• People with a history of certain serious or uncontrolled heart rhythm problems
• People showing clear signs of dementia or significant changes in mental functioning
• People with severe heart failure (classified as Grade III or IV on a standard heart function scale)
• People taking full-dose long-acting blood thinners or clot-dissolving medications for treatment purposes (short-acting blood thinners for prevention may be permitted)
• People who have had significant bleeding events, a history of bleeding from oesophageal varices, or a clinically significant history of upper gastrointestinal bleeding within the past 12 months
• People with a clear tendency or risk of bleeding
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with any other condition, treatment, or test result that, in the investigator's judgement, could affect safety or the reliability of the study results
• People who have had major surgery within 2 weeks before the blood collection procedure, or who have planned surgery during the study or within 4 weeks after treatment (minor procedures under local anaesthetic may be acceptable)
• People who still have unresolved side effects of Grade 2 or above from previous cancer treatments (with some exceptions such as hair loss or specific nerve-related effects, which may be discussed with the study team)
• People with alcohol or drug dependency
• People with a confirmed HTLV infection (a specific viral infection confirmed by antibody testing)

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