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:

• Adults aged 18 or older at the time of signing the consent form
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) confirmed by tissue testing
• People whose liver cancer is at an advanced stage (BCLC stage C), or at an intermediate stage (BCLC stage B) that is not suitable for local treatments, has stopped responding to local treatments, and cannot be treated with curative intent
• People who have not previously received any systemic (whole-body) drug treatment for their liver cancer — note that prior local treatments such as TACE are permitted
• People who have at least one tumour that can be measured on scans according to standard criteria (RECIST v1.1), either in an area not previously treated locally, or in a previously treated area where the cancer has since been confirmed to have grown
• People whose liver is functioning at a level rated "Child-Pugh class A," confirmed within 7 days before joining the trial
• People whose general physical fitness and ability to carry out daily activities is rated at 0 or 1 on a standard medical scale (ECOG score)

Who may not be able to join:

• People whose liver cancer is a specific less common type, including fibrolamellar, sarcomatoid, or mixed hepatocellular-cholangiocarcinoma
• People whose cancer has spread into the main portal vein or the large vein running from the abdomen to the heart (inferior vena cava)
• People who have received local liver treatments (such as chemoembolisation, embolisation, hepatic arterial infusion, radiotherapy, radioembolisation, or ablation) or any immune-boosting therapy (such as interleukin, interferon, or thymosin) within 28 days before joining
• People who have used traditional Chinese medicine or patent medicines intended to control cancer within 14 days before joining
• People who have a history of, or currently have, a moderate or severe form of confusion caused by liver disease (grade 2 or higher hepatic encephalopathy)
• People who have fluid around the heart, uncontrolled fluid around the lungs, or a clinically significant build-up of fluid in the abdomen — defined as fluid detectable by physical examination or fluid that has required drainage during the screening period
• People who have had a serious allergic reaction to another monoclonal antibody (a type of targeted drug) in the past
• People who have had bleeding from oesophageal or stomach varices (enlarged veins that can bleed) during screening or in the 6 months before joining
• People who still have side effects from previous cancer treatments that have not returned to their normal baseline or stabilised (hair loss is an exception)
• People who have had a serious bleeding or blood-clotting event within 6 months before screening, or who are currently taking blood-thinning medications that require regular monitoring (such as warfarin)
• People who have had another active cancer within the past 2 years, other than the liver cancer being studied or certain fully treated early skin or superficial cancers
• People who have cancer that has spread to the brain or the lining of the brain or spinal cord
• People who have an active immune system disorder or autoimmune disease, or a history of one that could return
• People who are currently taking moderate-to-high dose steroid tablets or other medicines that suppress the immune system within 14 days before screening (confirm with trial site regarding specific dose thresholds)
• People who have a history of scarring lung disease or non-infection-related lung inflammation, unless it was caused by radiation treatment
• People who have a serious active infection requiring ongoing antibiotic, antifungal, or antiviral treatment (such as tuberculosis), or who have a known HIV infection — note that viral hepatitis does not exclude participation
• People whose overall health, in the treating doctor's judgement, could put them at risk from the study treatment or make it difficult to assess any side effects
• People who have had an organ transplant or bone marrow/stem cell transplant, or who have received a live vaccine within 4 weeks before joining — note that standard inactivated flu vaccines are generally permitted, but nasal spray flu vaccines are not
• People who have had major surgery within 28 days before joining
• People who are currently breastfeeding

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