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 diagnosed with hepatocellular carcinoma (a type of liver cancer) confirmed by tissue or cell testing, where the cancer is at an advanced stage that cannot be removed by surgery and/or has spread to other parts of the body.
• People who have at least one tumor that can be measured using standard imaging criteria (RECIST v1.1).
• People whose liver scarring (cirrhosis) is rated as Child-Pugh class A or B, with no brain confusion caused by liver disease (encephalopathy), though fluid buildup (ascites) controlled by water tablets is allowed.
• People who can provide a sample of tumor tissue (a previously collected archived sample is acceptable) before the screening process begins.
• People whose general physical ability and daily functioning is rated at 0, 1, or 2 on a standard medical scale (ECOG performance status).
• Both men and women who are willing to use adequate barrier contraception (such as condoms) throughout the trial and for 4 weeks after it ends.
• People whose blood, liver, and kidney test results from within 7 days before joining meet all of the following levels (confirm with trial site):
  • Hemoglobin above 100 g/L
  • Absolute neutrophil count above 3.0 ×10⁹/L
  • Neutrophil count above 1.5 ×10⁹/L
  • Platelet count at or above 50.0 ×10⁹/L
  • Total bilirubin below 51 μmol/L
  • Liver enzymes (ALT and AST) below 5 times the upper limit of normal
  • Albumin (a blood protein) above 28 g/L
  • Blood clotting measure (PT-INR) below 2.3, or PT less than 6 seconds above the control value
  • Serum creatinine (a kidney marker) below 110 μmol/L
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required laboratory tests.

Who may not be able to join:

• People who have received local liver cancer treatments within the past 4 weeks, including surgery, tumour burning or freezing (ablation), chemoembolization (TACE or TAE), or radiation therapy.
• People who have a history of serious liver complications, such as fluid buildup that cannot be controlled, bleeding from the digestive tract, or confusion caused by liver failure.
• People who have uncontrolled serious health conditions, including active infections (other than hepatitis B or C), heart failure symptoms, uncontrolled diabetes, uncontrolled high blood pressure, unstable chest pain (angina), uncontrolled heart rhythm problems, active lung inflammation (ILD), severe ongoing digestive disease with diarrhoea, or significant mental health or social conditions that affect the ability to provide written consent.
• People with a history of active immune deficiency conditions or HIV infection.
• People with active or past autoimmune or inflammatory diseases, such as inflammatory bowel disease, lupus, sarcoidosis, Wegener's syndrome, rheumatoid arthritis, or related conditions (confirm with trial site for full list of exceptions).
• People known to have allergic or hypersensitivity reactions to any of the study drugs or their ingredients.
• People who had significant gastrointestinal bleeding or were identified by a doctor as being at significant risk of bleeding in the 30 days before joining the trial.
• People who have cancer that has spread to the brain or other parts of the central nervous system.
• People who are pregnant or breastfeeding.
• People who have another current or recent cancer diagnosis, with certain exceptions for cancers that have been fully treated, show no signs of return for at least 5 years, carry a low risk of coming back, or are fully treated non-melanoma skin cancers or carcinoma in situ with no evidence of disease (confirm with trial site).
• People who are currently using, or have used within the past 14 days, medicines that suppress the immune system — with some exceptions for low-dose or topical steroids and steroids used to prevent allergic reactions (confirm with trial site for full list of exceptions).
• People who have received a live vaccine within 30 days before the first dose of the study drug.
• People with high blood pressure that remains uncontrolled (systolic at or above 160 mmHg, or diastolic at or above 100 mmHg) despite blood pressure medication in the 28 days before starting the trial.
• People who are pregnant, breastfeeding, or fertile men and women who are unwilling to use highly effective contraception from screening through to 6 months after the last dose of the study treatment.

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