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:

• The participant, or their legally authorised representative, must be able to understand the study and be willing to sign a written consent form.
• Adults aged 18 years or older of any sex.
• People who are generally well enough to carry out normal daily activities with little to no restriction (confirm with trial site for exact fitness level required).
• People who have been diagnosed through a tissue biopsy with liver cancer (hepatocellular carcinoma, or a mixed type of liver and bile duct cancer) that has either spread locally or to other parts of the body.
• People whose cancer cannot be removed by surgery and who are not candidates for a liver transplant.
• People whose liver is functioning at a certain level, as measured by a standard liver scoring system, within 14 days before joining (confirm with trial site).
• People whose tumour is generally between 4 and 12 cm in size, though larger tumours may be considered if radiation to surrounding healthy tissue can be kept within safe limits.
• Women who could become pregnant must have a negative blood pregnancy test within 48 hours before starting treatment, and must agree to use effective contraception or remain sexually abstinent during the study and for at least 12 months after finishing treatment.
• Men who could father a child must agree to use effective contraception or abstain from sex during the study and for at least 12 months after their last treatment, and must not donate sperm during this time.
• Blood counts and organ function must meet certain minimum levels, including: haemoglobin (a measure of red blood cells) of at least 8 g/dL (blood transfusions are allowed to help reach this level), a certain minimum level of infection-fighting white blood cells, platelets above a minimum threshold, liver enzyme levels below a certain limit, protein (albumin) in the blood above a minimum level, blood clotting within an acceptable range, kidney function within an acceptable range, and bilirubin (a waste product processed by the liver) below a certain limit.
• People with swollen veins in the food pipe (oesophageal varices), if present, must have mild ones only and must not have had any bleeding from them in the past 6 months.
• People must have had blood tests to check for hepatitis B and hepatitis C, though having hepatitis does not automatically prevent participation if all other criteria are met.
• People with HIV may be eligible provided they are receiving effective HIV treatment, have an adequate immune cell count, and have no detectable virus in their blood at the time of joining (HIV testing is not required to apply).

Who may not be able to join:

• People whose liver cancer or mixed cancer type could potentially be treated with curative surgery or a liver transplant.
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the study requirements.
• People who are pregnant or breastfeeding.
• People who have previously had radiation treatment to the abdomen, including a type of internal radiation therapy using Yttrium.
• People with a history of autoimmune disease (where the immune system attacks the body's own tissues).
• People currently taking immune-suppressing medications, such as steroid tablets or certain anti-inflammatory drugs.
• People who currently have another active cancer, unless it is a slow-growing or already-treated skin cancer, treated chronic leukaemia of a specific type, or a prior cancer that has been in remission for 3 years or more.
• People whose tumour has grown directly into the stomach, small intestine, large intestine, or upper digestive tract, or who have severe untreated swollen veins in the food pipe.
• People whose liver cancer visibly involves the main bile ducts.
• People with serious active other health conditions (confirm with trial site for specifics).
• People who have had major surgery within 8 weeks before the first treatment dose, or who have not fully healed from surgery.
• People who have previously had an organ transplant.
• People with high blood pressure that cannot be controlled even with medication.
• People with uncontrollable fluid build-up in the abdomen or around the lungs.
• People who have had certain serious abdominal complications, such as a hole in the bowel, a blockage, or an abscess, within 8 weeks before the first dose.
• People with an active autoimmune disease that has required systemic (whole-body) medical treatment in the past 2 years.
• People with an immune deficiency condition, or those receiving ongoing steroid or immune-suppressing treatment within 7 days before the first dose (some limited steroid uses may be acceptable — confirm with trial site).
• People who have had significant active bleeding, such as coughing or vomiting blood, within the past 8 weeks.
• People diagnosed with bile duct cancer (cholangiocarcinoma) alone, whether inside or outside the liver.
• Participants must not donate blood or blood products during the study or for 180 days after the last dose.

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