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 liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed, or who have chosen not to have surgery, with no spread of cancer outside the liver (although spread to nearby lymph nodes is permitted)
• People whose liver cancer has been confirmed as suitable for a type of radiation treatment called Y90-SIRT (a procedure that delivers radiation directly to liver tumours through tiny beads injected into the blood vessels)
• People aged between 18 and 80 years old at the time of joining the trial
• People whose liver is functioning at a level doctors classify as "Child-Pugh class A" (a measure of how well the liver is working)
• People who are either fully active or have only minor limitations in daily activities, as rated by a standard medical scale called ECOG (score of 0 or 1)
• People whose lungs and remaining liver tissue meet specific safety thresholds required for the Y90 radiation treatment (confirm with trial site)
• People who have one or more measurable liver tumours; if there is limited involvement of certain blood vessels near the tumour, the disease must be confined to one side of the liver and be suitable for Y90 treatment
• People who have hepatitis B or hepatitis C infection, provided: hepatitis B is well controlled (virus levels below a specified threshold) and managed according to local guidelines; or hepatitis C antiviral treatment has been fully completed before starting the trial
• People who have not previously received any systemic (whole-body) cancer treatment or the Y90 glass microsphere type of radiation treatment
• People who do not have an active autoimmune disease and have no history of a long-term or recurring autoimmune condition
• People whose blood counts, liver function, and kidney function meet specific minimum levels as measured by blood tests (confirm with trial site for exact values)
• People who are not pregnant and do not plan to become pregnant before or during treatment
• People who are able and willing to provide written agreement to participate in the trial
• People who are expected to live for at least 12 weeks

Who may not be able to join:

• People whose liver cancer is spread widely throughout the liver, or where there is invasion of major blood vessels or spread beyond the liver (with the exception of limited involvement of certain smaller vessels)
• People whose liver function is classified as "Child-Pugh class C" (the most severely reduced level of liver function)
• People who have specific medical reasons that make the liver procedure unsafe, such as known problems with blood flow to the liver, certain blood clotting issues, kidney failure requiring dialysis, severe hardening of the arteries, or complete blockage of the main portal vein
• People with significant heart conditions, including moderate-to-severe heart failure, recent or active coronary artery disease, difficult-to-control heart rhythm problems, uncontrolled high blood pressure, or a significant episode of gastrointestinal bleeding within the past 4 weeks (a heart attack that occurred 6 or more months before joining may be permitted — confirm with trial site)
• People who have had a stroke, mini-stroke (TIA), deep vein blood clot, or a blood clot in the lungs within the 6 months before starting the trial (limited portal vein clotting may be an exception — confirm with trial site)
• People who have received systemic cancer treatment, radiotherapy, hormone therapy, immunotherapy, or other experimental treatments within 4 weeks before starting the trial
• People who are currently taking or have taken immune-suppressing medications within 28 days before starting the trial drugs (certain low-dose or topical steroids may be exceptions — confirm with trial site)
• People who have received a live vaccine within 30 days before starting the trial
• People who have had major surgery within 4 weeks before starting the trial, or who have not yet fully recovered from major surgery
• People who have had another type of cancer, unless it was a certain type of skin cancer or early-stage cervical cancer that was fully treated, or unless they have been free of that cancer for more than 3 years
• People with other serious uncontrolled health conditions, including active infections, certain heart or lung conditions, severe digestive problems, or mental health or social conditions that would make it difficult to follow the study requirements safely
• People with active tuberculosis, active hepatitis B infection (detected by a specific marker in the blood called HBsAg), or active hepatitis C (detected by a positive PCR test for the virus)
• People who have previously received an organ transplant from another person
• People with a psychiatric disorder or significantly altered mental state that would prevent them from understanding and agreeing to take part
• People with brain metastases (cancer that has spread to the brain) that are causing symptoms
• People who are pregnant or breastfeeding
• People who are known to be HIV positive
• People with an active or previously diagnosed autoimmune or inflammatory disease, such as inflammatory bowel disease, lupus, rheumatoid arthritis, sarcoidosis, or similar conditions
• People who have a known allergy or sensitivity to any of the study drugs or their ingredients
• People who are currently in, or have recently participated in, another clinical trial involving an experimental drug or device within 4 weeks before starting this trial

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