Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from the 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 or older at the time of signing the consent form who are willing and able to attend study visits and follow the study procedures
• People with advanced or inoperable liver cancer (hepatocellular carcinoma, or HCC) confirmed by biopsy, cell testing, or clinical assessment according to recognised medical guidelines
• People who have already been treated with at least one approved immune checkpoint therapy (a type of cancer drug that targets PD-1 or PD-L1) and at least one approved targeted therapy drug for liver cancer
• People whose liver cancer is classified as BCLC stage B (where local or surgical treatment is not suitable, or the cancer has returned or worsened after such treatment) or BCLC stage C
• People whose liver function is rated as Child-Pugh class A (a measure of how well the liver is working)
• People whose tumour tissue tests positive for a protein called FGF19 (a marker found in some liver cancers)
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (ECOG score)
• People expected to live for at least 3 more months
• People with adequately controlled blood pressure at the time of screening
• People with adequate liver, kidney, and bone marrow function as assessed by blood tests
• People who are not surgically sterilised and could potentially have children must agree to use reliable contraception from at least 2 weeks before joining the trial until 1 month after the last dose of the study treatment

Who may not be able to join:

• People with a known allergy or sensitivity to any ingredient in the study drug (ABSK-011) or the placebo
• People who have previously been treated with a selective FGFR4 inhibitor (a specific type of targeted therapy)
• People whose liver cancer is a specific rare subtype, including fibrolamellar HCC, sarcomatoid HCC, or a mixed liver-bile duct cancer
• People who received any anti-cancer treatment less than 4 weeks before joining the trial
• People who had major surgery within 4 weeks before joining, have a wound that has not fully healed within 2 weeks before joining, or have major surgery planned during the study
• People who have had a second unrelated cancer within the past 5 years (other than the liver cancer being studied)
• People whose liver tumours take up 50% or more of the total liver volume
• People who still have significant side effects (above a mild level) from previous cancer treatments that have not resolved
• People whose cancer scans show the tumour has grown into major blood vessels such as the main portal vein, inferior vena cava, or heart
• People with significant heart problems or reduced heart function
• People who have both hepatitis B and hepatitis C infections at the same time
• People with HIV or an AIDS-related illness
• People who have had active gastrointestinal (digestive tract) bleeding within the past 6 months
• People with uncontrolled fluid build-up around the lungs or heart requiring treatment within 2 weeks before joining, or significant fluid build-up in the abdomen
• People who have ever had, or currently have, a condition where the liver fails to remove toxins from the blood, causing confusion or other brain symptoms (hepatic encephalopathy, any severity)
• People whose cancer has spread to the brain or spinal cord lining
• People who have had an organ transplant and are taking anti-rejection medications
• People who have conditions that significantly affect how the body absorbs medicines taken by mouth (confirm with trial site)
• People who have taken certain medications that affect how the body processes drugs (specific P-gp or CYP3A4 inhibitors or inducers) within 2 weeks before joining
• People who have had a serious infection requiring antibiotic, antifungal, or antiviral treatment within 2 weeks before joining
• People who cannot have contrast-enhanced CT or MRI scans due to allergies to the contrast dye or other medical reasons
• People with any other significant health condition that could affect their safety, wellbeing, ability to consent, or ability to follow the study procedures

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