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 have been clearly diagnosed with hepatocellular carcinoma (a type of liver cancer) that is large or advanced within the liver, but has not spread outside the liver, and meets specific size or blood vessel involvement criteria as assessed by both the local site and a central imaging review team.
• People aged 21 years or older, of any gender.
• People whose liver cancer is assessed as suitable for a type of internal radiation treatment (SIRT-Y90), based on a pre-treatment scan showing that less than 20% of the radiation would reach the lungs, and that radiation dose limits to the lungs would not be exceeded.
• People who have not previously had radiation treatment to the liver.
• People who have not previously received systemic therapy (such as chemotherapy or targeted medicines given throughout the body) aimed at treating liver cancer before or after surgery.
• People who have at least one tumour that can be measured accurately on a scan (at least 10mm in its longest dimension).
• People who test negative for HIV, or who are HIV-positive but are stable on anti-HIV medication, have an adequate immune cell count, and have an undetectable level of the virus in their blood.
• People who have had their hepatitis B and hepatitis C status confirmed through blood tests at screening.
• People with active hepatitis B who have a low enough level of the virus in their blood and have been on hepatitis B treatment for at least 14 days before joining the trial, and are willing to continue that treatment during the study.
• People who are in good general health, able to carry out light activity and care for themselves (confirm with trial site for the specific score used).
• People whose liver function meets a specific standard known as Child-Pugh A (up to 6 points) (confirm with trial site).
• People whose blood counts, kidney function, and liver function all meet specific minimum levels as measured by blood and urine tests (confirm with trial site for exact values).
• People who are expected to live for at least 3 months without active treatment.
• People who the treating doctor at the trial site considers suitable for the study treatment.
• People who have had a camera examination of the food pipe and stomach (called an endoscopy) within 6 months before joining the trial, and who have had any swollen veins in those areas fully treated beforehand.
• People who are willing and mentally able to give written consent to participate in the study.
• Female patients who are past menopause, or if still of childbearing potential, who have a negative pregnancy test and agree to use two forms of contraception during treatment and for at least 5 months after the last dose of one study drug and 6 months after the last dose of another.
• Male patients who are surgically sterilised, or who agree to use an acceptable form of contraception during treatment and for 6 months after the last dose of one of the study drugs, if their partner could become pregnant.

Who may not be able to join:

• People who are found not to be suitable for the SIRT-Y90 internal radiation treatment based on their pre-treatment scan results.
• People who have had a severe side effect (grade 3 or above) within 4 weeks after receiving SIRT-Y90 treatment (though a waiting period and re-assessment may be possible in some cases — confirm with trial site).
• People who have had more than two previous treatments directed at the liver through the blood vessels (such as chemoembolisation).
• People who have had a liver-directed treatment through the blood vessels less than 4 weeks before signing the consent form.
• People who have previously received systemic therapy as a treatment before or after surgery for liver cancer.
• People who have previously had radiation treatment to the liver for any cancer.
• People who have received immune-based treatments (such as interferon or similar medicines) within 30 days before joining the trial, are currently receiving them, or are planned to receive them during the study.
• People where less than 30% of their total liver volume is free of disease.
• People currently receiving another experimental treatment for their cancer.
• People who have persistent fluid build-up in the abdomen that cannot be controlled with medication, or other signs that the liver is failing.
• People who have swollen veins in the food pipe or stomach that have not been treated or have only been partially treated before joining the trial.
• People whose cancer has spread into the main portal vein or certain other major blood vessels beyond specific limits, or into the main vein leading to the heart (confirm with trial site for exact vessel involvement criteria).
• People who have cancer that has spread to lymph nodes (measuring 15mm or more) or to other parts of the body outside the liver.
• People who have another active cancer, unless it is a certain type of skin cancer, cervical cancer in its earliest stage, or a cancer for which they have been free of disease for at least five years.
• People who show signs that their cancer has spread to the brain or nervous system.
• People with serious uncontrolled illness, such as active infection (other than hepatitis), heart failure, unstable chest pain, abnormal heart rhythm, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People with high blood pressure that is not adequately controlled (above 150/100 mmHg on average across at least three separate readings), even with blood pressure medication.
• People who have bleeding disorders that cannot be corrected, or severe blood vessel disease in the limbs that would prevent a catheter being inserted into an artery, as these would make the procedure unsafe.
• People who have had a significant heart attack, stroke, or serious heart condition within 3 months before joining, or who have an unstable heart rhythm or unstable chest pain.
• People with a history of a specific inherited heart condition affecting the heart's electrical signals, or who have a certain abnormal heart reading (QT interval over 500ms) on an ECG at screening.
• People with a long-term, uncorrectable imbalance of certain minerals in the blood (potassium, calcium, or magnesium).
• People who have recently taken high-dose aspirin or certain blood-thinning medications within 10 days before the procedure (some exceptions may apply — confirm with trial site).
• People who have recently taken full-dose blood thinners or clot-dissolving medicines within 10 days before the procedure (some limited exceptions for low-dose preventive use may apply — confirm with trial site).
• People who have had an allergic reaction to medicines that are similar in composition to any of the study drugs.
• People who have an active autoimmune disease (where the immune system attacks the body) or a significant immune deficiency condition, such as multiple sclerosis, lupus, or inflammatory bowel disease (some specific exceptions for certain well-controlled conditions may apply — confirm with trial site).
• People who need ongoing treatment with medicines that suppress or stimulate the immune system, or who require long-term steroid treatment (more than 7 days in a row).
• People who are unable or unwilling to give written informed consent.
• Female patients who are pregnant or breastfeeding.
• People who are already enrolled in another clinical trial testing an experimental medicine or device.

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