Early 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:

• Adults aged 18 or older
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer), either confirmed by a tissue sample (biopsy) or by MRI or CT scan showing typical signs of liver cancer alongside liver cirrhosis
• People whose liver cancer is classified as an intermediate or limited advanced stage (known as BCLC Stage B or limited Stage C), and those with the more advanced stage must have already received, or been offered and declined, systemic (whole-body) drug treatment
• People whose liver cancer did not respond well to previous local treatments (such as procedures targeting the liver directly) or to one or more systemic drug treatments
• People for whom surgery to remove the cancer, a liver transplant, or a needle-based ablation procedure is not considered a suitable option by their medical team
• People who are generally well enough to carry out light activity and care for themselves (a standard medical fitness measure scored at 0 or 1 out of 5)
• People whose blood test results fall within acceptable ranges for liver function, kidney function, blood clotting, and blood cell counts (confirm specific values with the trial site)
• People whose blood oxygen level while breathing normal room air is above 90%
• People whose liver disease is not too advanced, based on a standard liver health scoring system called Child-Pugh (score of A or B7), and who do not have significant fluid build-up in the abdomen
• People who are willing and able to sign a consent form agreeing to take part
• People who have had a surgical procedure to prevent pregnancy, women who have been through menopause for at least two years, or people who agree to use effective contraception approved by the trial doctor for at least two months after their final dose of the study treatment

Who may not be able to join:

• People whose liver cancer meets the Milan criteria, meaning a liver transplant is currently considered a suitable option for them, or who may become eligible for a transplant after treatment to shrink their tumour
• People who have previously had an organ transplant
• People who have received certain liver cancer treatments within specific timeframes before joining — small molecule drugs or local liver procedures (such as TACE) within the past 30 days, biological or investigational therapies within the past 60 days, or Y90 radioembolisation within the past 90 days
• People who have had another cancer in the past two years that has not been fully cleared, with the exception of certain low-risk or easily treated cancers such as non-melanoma skin cancer, in-situ cancer, or low-grade prostate or bladder cancer
• People with serious lung disease that causes low oxygen levels and requires supplemental oxygen, or who have significant fluid around the lungs
• People with serious heart conditions, including advanced heart failure (Class III or IV), a heart attack within the past three months, an unstable irregular heartbeat, significant disease of the blood vessels in the limbs, or an artificial heart valve or other vascular device that requires ongoing blood-thinning medication
• People with certain heart rhythm concerns, including a prolonged QT interval on a heart tracing (ECG), a history of conditions or family history that increase the risk of a dangerous heart rhythm called Torsades de Pointes, or who are taking medications known to affect heart rhythm (confirm current medications with the trial site)
• People who have had major surgery, a serious vascular injury, or a significant illness within the past 60 days
• People with an inherited condition that causes the blood to clot too easily, or who have a history of blood clots that occurred without a clear cause
• People with active, uncontrolled infections (bacterial, viral, or fungal) that require ongoing treatment; people with hepatitis B must have a very low viral level or be receiving appropriate treatment with a maintained low viral level for at least four weeks before starting the trial
• Women who are currently breastfeeding
• People who have a serious allergy to iodine-based contrast dye used in imaging scans that cannot be managed with medication
• People who are on blood-thinning medication that cannot safely be paused before and after the treatment procedure (confirm with the trial site)
• People with any other medical condition or situation that, in the opinion of the trial doctor, could interfere with the study or pose an unacceptable risk
• People who are unwilling or unable to follow the trial's requirements for any reason

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