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 aged between 40 and 70 years old.
• People diagnosed with advanced liver cancer (confirmed by a tissue or cell sample) that cannot be treated with surgery or local treatments, and whose cancer has worsened or who could not tolerate standard treatments.
• People whose previous treatment with a PD-1 immunotherapy drug was stopped due to it not working, with at least 28 days having passed since stopping.
• People who have at least one measurable tumour that meets specific size requirements as assessed by standard imaging scans.
• People whose tumour tissue tests positive for a protein called GPC3 on a laboratory test.
• People whose liver cancer is classified as Barcelona stage C, or stage B where local treatment is not suitable or has stopped working.
• People whose doctors estimate they are likely to live for more than 12 weeks.
• People whose liver function is rated as Child-Pugh Grade A (a measure of how well the liver is working).
• People whose general physical fitness is rated 0 or 1 on a standard scale used in cancer research (meaning fully active or able to carry out light activity).
• People who test positive for certain hepatitis B markers must have a low hepatitis B virus level in the blood and must be receiving antiviral treatment as required by clinical guidelines.
• People who have suitable vein access for treatment.
• People whose blood test results meet specific minimum levels for white blood cells, platelets, haemoglobin, and a type of white blood cell called lymphocytes (confirm specific values with trial site).
• People whose blood chemistry results — including measures of liver function, kidney function, and certain enzymes — fall within the ranges required by the trial (confirm specific values with trial site).
• Women of childbearing age who test negative for pregnancy before the trial starts and who agree to use reliable contraception for 12 months after treatment; male participants whose partners could become pregnant must either have had a sterilisation procedure or agree to use reliable contraception during the trial.
• People who are able to understand and sign a consent form agreeing to take part.

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People who test positive for hepatitis C, HIV, or syphilis.
• People with any active infection that cannot be controlled, including active tuberculosis.
• People who have taken steroid medications (above a certain dose) within 2 weeks before a required cell collection procedure, except for inhaled steroids.
• People with known allergies to immunotherapy drugs, or who have had a severe allergic reaction to a class of antibiotics called beta-lactams.
• People who have had, or currently have, a condition called hepatic encephalopathy (where the liver cannot remove toxins, affecting the brain).
• People who currently have a significant build-up of fluid in the abdomen (ascites) that shows up on physical examination or requires medical procedures or drugs to manage.
• People whose imaging scans show that tumour covers 50% or more of the liver, or that there are blood clots caused by the tumour in certain major blood vessels.
• People who have cancer that has spread to the brain or spinal cord, or who have significant diseases of the central nervous system.
• People who currently have a heart condition requiring treatment, or high blood pressure that is not well controlled (confirm specific blood pressure thresholds with trial site).
• People with known active autoimmune diseases that require treatment with immune-suppressing medications, including biological drugs.
• People who have previously had an organ transplant or are on a waiting list for one, including a liver transplant.
• People who have received any treatment for their liver cancer — including surgery, radiation, chemotherapy, or immunotherapy — within 2 weeks before the cell collection procedure.
• People who have received a treatment specifically targeting GPC3, or certain cell-based therapies (TCR-T or CAR-T), within the past month.
• People who have received anti-PD-1 or anti-PD-L1 immunotherapy within the past 28 days.
• People who have had another cancer that cannot be cured within the past 5 years or currently, not counting certain early-stage skin or cervical conditions.
• People with other serious health conditions, such as poorly controlled diabetes, severe heart failure, a recent heart attack, certain heart rhythm problems, unstable chest pain, blood clots in the lungs, chronic lung disease, significantly reduced lung function, stomach ulcers, or a history of gastrointestinal bleeding (confirm specific thresholds with trial site).
• People who the trial doctor believes are unable or unwilling to follow the requirements of the trial.

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