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 aged 18 to 75 years
• People who have liver cancer (hepatocellular carcinoma, or HCC) that doctors have determined can be removed by surgery, and which falls into an early-to-intermediate stage (classified as BCLC A or B)
• People who have not yet received any treatment for their liver cancer
• People whose liver cancer is considered high risk for coming back after surgery, meaning at least one of the following applies: there are multiple tumours; a single tumour is larger than 5 cm; a specific protein in the blood called AFP is above a certain level; or a scan suggests microscopic spread into nearby blood vessels
• People whose tumour(s) can be measured or assessed using standard imaging methods
• People who are generally well enough to carry out daily activities with little or no limitation (a score of 0 or 1 on a standard activity scale used by doctors)
• People whose liver is functioning at a good level (classified as Child-Pugh class A)
• People with a life expectancy of at least 12 weeks
• People whose blood tests show the body's organs and bone marrow are functioning well enough — including adequate levels of red blood cells, white blood cells, platelets, liver enzymes, kidney function, and blood clotting markers (confirm specific values with trial site)
• Women who could become pregnant must have a negative pregnancy test before joining
• People who have or have had another type of cancer, where that cancer or its treatment is not expected to interfere with this trial, as assessed by the treating doctor
• People who are willing and able to understand and sign a written consent form

Who may not be able to join:

• People who have previously received any treatment for liver cancer
• People whose tumour has ruptured or bled, or where there is suspected spread of cancer within the abdomen
• People who have had a major surgery, open biopsy, or serious injury with a wound that has not healed properly within the 6 weeks before joining
• People who have had an organ transplant from another person
• People who are currently participating in another clinical trial
• People with a current or past history of autoimmune or inflammatory conditions (such as Crohn's disease, colitis, lupus, rheumatoid arthritis, and similar conditions) — though some milder conditions such as well-controlled skin conditions, diet-controlled coeliac disease, or stable thyroid conditions on hormone replacement may be exceptions (confirm with trial site)
• People with a known allergy to the study drug (AK104) or to similar immune checkpoint inhibitor drugs
• People with poorly controlled ongoing illness, such as an active infection (including tuberculosis), blood pressure that remains too high despite medication, lung disease, serious bowel conditions, or significant mental health or social circumstances that could affect participation
• People with a history of brain dysfunction caused by liver disease (hepatic encephalopathy), severe fluid build-up in the abdomen that does not respond to treatment, high-risk enlarged veins in the food pipe or stomach, or a bleed in the upper digestive tract within the past year
• People with active, untreated hepatitis B virus infection at certain levels; or active hepatitis C infection (confirm specific test thresholds with trial site)
• People with a brain tumour (except certain benign types), cancer that has spread to the brain, seizures not controlled by standard medication, or a stroke within the past year
• People with a history of a primary immune deficiency condition
• People who have tested positive for HIV or have AIDS
• People who have used immune-suppressing medications in the 14 days before starting the trial — though some specific low-dose or localised steroid uses may be exceptions (confirm with trial site)
• People who have received a live vaccine within 30 days before starting the trial
• People who have received treatments designed to stimulate the immune system within 14 days before starting the trial
• People with a history of serious heart or blood vessel conditions within the past 12 months, such as a heart attack, unstable chest pain, heart failure, serious irregular heartbeat, or significant vascular disease
• People with a history of abnormal blood clotting or a blood clot within the past 12 months
• People with a wound, ulcer, or bone fracture that is not healing
• People who are pregnant or breastfeeding
• People receiving nutrition entirely through a drip into a vein (total parenteral nutrition)
• People excluded at the discretion of the trial investigators due to other health or personal factors that could affect safe participation in the study

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