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 are able to understand and sign a written consent form
• People who are older than 18 years of age
• People who have been confirmed through a tissue test (biopsy) to have liver cancer (HCC) that can be surgically removed and is at an early or intermediate stage
• People who agree to have a biopsy sample taken before treatment begins
• People whose general health and ability to carry out daily activities meets a specific standard (an ECOG score of 0 or 1, meaning fully active or able to carry out light activity)
• People whose liver function meets a specific standard (a Child-Pugh score of 5 or 6 and an ALBI grade of 1, both indicating relatively well-preserved liver function — confirm with trial site)
• People with a hepatitis B (HBV) infection who are already on, or are able to start, antiviral treatment to bring the virus to a low enough level before joining the trial, and who agree to stay on antiviral therapy throughout the trial and for 6 months after the last treatment dose
• People with hepatitis B core antibodies but undetectable virus levels, who do not need antiviral therapy to start but will be monitored regularly throughout the trial
• People with a hepatitis C (HCV) infection who are being managed according to their local hospital's standard practice
• Women who have gone through menopause, or women of childbearing age who have a negative blood pregnancy test before joining
• Women of childbearing age and male partners of women of childbearing age who agree to use effective contraception from the start of screening until 6 months after the last treatment dose (not being sexually active for this period is also accepted)
• People whose blood and organ function test results fall within the required ranges, including adequate levels of red blood cells, white blood cells, platelets, liver enzymes, kidney function, albumin (a blood protein), and blood clotting (confirm exact values with trial site)
• People who are willing and able to follow the trial schedule, including attending all required visits and examinations
• People who weigh more than 30 kg

Who may not be able to join:

• People whose liver cancer is of a specific rare type, including fibrolamellar HCC, sarcomatoid HCC, or a mixed liver and bile duct cancer
• People who have had any previous treatment for liver cancer, except for a single liver surgery or ablation (a procedure to destroy tumour tissue) that was done with the aim of curing the cancer and took place at least two years before joining the trial
• People whose scans show the cancer has spread to distant parts of the body, has invaded major blood vessels, or who have another active cancer at the same time
• People who have had episodes of confusion caused by liver failure (hepatic encephalopathy) in the 12 months before joining, or who need certain medications to prevent it
• People whose scans show a blood clot in the main vein supplying the liver (portal vein thrombosis)
• People who have had significant fluid build-up in the abdomen (ascites) requiring a draining procedure within the 6 months before joining (people whose fluid build-up has been stable and managed with water tablets for at least 2 months before joining may still be considered)
• People who have a history of serious kidney conditions involving protein leakage (nephrotic or nephritic syndrome)
• People with significant heart failure or poorly controlled irregular heartbeat
• People with an active or previously documented autoimmune or inflammatory condition such as Crohn's disease, lupus, or rheumatoid arthritis (some exceptions apply — confirm with trial site)
• People with other serious uncontrolled health conditions, including active infections, uncontrolled high blood pressure, unstable heart conditions, active lung inflammation, severe ongoing diarrhoea, or significant mental health conditions that would make it difficult to follow the trial requirements
• People with a history of another cancer, with some exceptions including certain low-risk or successfully treated cancers (confirm with trial site)
• People who are currently receiving any other chemotherapy, cancer-targeted therapy, or cancer hormone therapy (hormone therapy for non-cancer conditions is permitted)
• People with an active infection including tuberculosis or HIV
• People with active co-infection of both hepatitis B and hepatitis C, or both hepatitis B and hepatitis D
• People who have a known allergy or sensitivity to any of the study medications or their ingredients
• People who have had a major surgical procedure within 28 days before joining, or a central line (a type of intravenous access device) placed within 7 days before joining
• People whose heart rhythm measurement (QTcF interval) is at or above a specific threshold on an electrocardiogram (ECG) (confirm with trial site)
• People with a history of a primary immune system deficiency condition
• People who have previously received an organ transplant from a donor, or who are currently on a waiting list for a liver transplant
• People who have received a live vaccine within 30 days before the first treatment dose (and live vaccines are also not permitted during the trial or for 90 days after the last dose)
• People who have used immune-suppressing medications within 14 days before the first dose, with some exceptions such as low-dose inhaled, topical, or very low-dose oral steroids (confirm with trial site)
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use highly effective birth control from the screening period until 6 months after the last treatment dose

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