Phase 1 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 are willing to take part and sign a consent form agreeing to join the study.
• People aged 18 to 80 years old (inclusive), of any gender.
• People who have been diagnosed with liver cancer (hepatocellular carcinoma) either through clinical assessment or confirmed by a tissue sample (pathology).
• People whose overall physical functioning is rated as good or only slightly limited, based on a standard medical scale (ECOG score of 0 or 1).
• People whose liver is functioning at a level rated as Child-Pugh score A, or a B score of 7 or below.
• People whose doctors have assessed that surgery or ablation (a procedure to destroy the tumour) is not currently a suitable option for them, or people who have chosen not to undergo surgery or ablation.
• People who have at least one measurable liver tumour that is 1 cm or larger in size on a contrast-enhanced MRI or CT scan, as assessed using a standard measurement method called mRECIST.
• People whose doctors estimate they are likely to survive for at least 3 months.
• People whose cancer has not spread outside the liver and who do not have any other type of cancer.
• People whose blood, liver, kidney, clotting, and heart function all meet specific levels required by the trial (confirm exact values with the trial site).
• People who have recovered from side effects of any previous cancer treatments, or whose remaining side effects are mild and stable (confirm details with trial site).
• People of childbearing potential who agree to use reliable contraception throughout the study and for 6 months after it ends, and whose pregnancy test is negative before starting; male participants must also agree not to donate sperm during this period.

Who may not be able to join:

• People with severe liver problems, such as serious jaundice, brain confusion caused by liver failure (hepatic encephalopathy), fluid build-up in the abdomen that is hard to treat, or kidney failure related to liver disease.
• People whose doctors assess them as suitable candidates for surgery or ablation to remove or destroy the tumour.
• People who have previously had external radiation therapy directed at the liver area.
• People with serious lung problems, including severe chronic obstructive pulmonary disease or scarring/inflammation of the lung tissue (interstitial pneumonia), based on specific breathing test results (confirm details with trial site).
• People whose scan results show that too much blood is being redirected from the liver to the lungs, or where the radiation dose to the lungs would exceed safe limits (confirm details with trial site).
• People whose imaging tests show abnormal connections between liver blood vessels and the digestive system that cannot be corrected with a procedure.
• People for whom a tube cannot be safely inserted into the liver artery — for example, due to blood vessel abnormalities, or allergy to contrast dye or anaesthetic.
• People who have a blood clot (tumour thrombus) in the main portal vein of the liver.
• People who received any anti-cancer treatment (such as surgery, chemotherapy, immunotherapy, or targeted therapy) less than 4 weeks before starting this trial.
• People who have taken part in another clinical study within 4 weeks before starting this trial.
• People who are expected to need any other form of cancer treatment during the study period.
• People who have received a live vaccine within 28 days before starting the trial, or who plan to receive one within 60 days after treatment ends.
• People with a previous history of epilepsy (seizures).
• People who have had major surgery (not including a needle biopsy) or a serious injury within 4 weeks before starting the trial, or who are expected to need planned surgery during the trial.
• People who have previously had a bone marrow transplant or a solid organ transplant (such as a kidney or liver transplant).
• People with active or untreated tuberculosis (those who have completed a full course of tuberculosis treatment and are confirmed cured may still be considered — confirm with trial site).
• People who have had a significant active infection requiring antibiotic treatment within 2 weeks before starting the trial.
• People who have been diagnosed with an immune system deficiency disorder or who test positive for HIV.
• People who have had a significant heart or brain blood vessel problem within the 6 months before starting the trial — including heart attack, severe chest pain (unstable angina), stroke, serious heart failure, certain abnormal heart rhythms, or blood pressure that remains too high despite medication (confirm specific details with trial site).
• People with a history of a lung condition called interstitial lung disease (ILD), or any currently active lung inflammation.
• People with a known mental health condition that would make it difficult to follow the trial requirements, or that requires ongoing medication to manage.
• People who are pregnant or breastfeeding.
• People with any serious medical or mental health condition, or significant abnormal test results, that the doctor believes would make participation unsafe or affect the reliability of the study results.
• People who, in the doctor's judgement, have any other circumstances that would make safe or full participation in the trial difficult.

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