Phase 3 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 of any sex
• People who have been diagnosed with hepatocellular carcinoma (liver cancer), confirmed either by tissue biopsy (for those without liver scarring/cirrhosis) or by a recognised specialist guideline process (for those with cirrhosis)
• People whose liver cancer is advanced — meaning it has spread or has not responded to treatment, and standard treatments are not expected to cure it
• People whose liver cancer has gotten worse after trying at least one, but no more than two, previous systemic (whole-body) drug treatments; prior local treatments to the liver are also allowed
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) Stage B or C (a staging system used by liver specialists — confirm with trial site)
• People who stopped their last liver cancer treatment at least 2 weeks before the trial's starting assessment
• People who have measurable tumour(s) that can be tracked using standard imaging guidelines
• People with a good general performance level — able to carry out light activity and self-care (ECOG performance score of 0 or 1)
• People whose liver scarring (cirrhosis), if present, is rated at a specific severity level called Child-Pugh B7 (confirm with trial site for exact scoring details)
• People whose recent blood test results (taken within 10 days before the first dose) meet all of the following: sufficient white blood cell counts, platelet counts, and kidney function; liver enzyme levels no more than 5 times the upper limit of normal; total bilirubin no higher than 3.0 mg/dL; and blood protein (albumin) levels of at least 2.8 g/dL
• People with a life expectancy of at least 6 weeks
• Women who could become pregnant must have a negative blood pregnancy test before joining
• People who are willing and able to give written consent to participate
• People who are willing to attend scheduled visits, follow the treatment plan, and complete required tests and procedures

Who may not be able to join:

• People who have previously received more than two systemic (whole-body) drug treatments for liver cancer
• People who have received systemic cancer therapy, immune-modifying drugs, immunosuppressants, or corticosteroids above a certain dose within 14 days before the starting assessment, or who would need these during the trial
• People who had a local liver treatment within 4 weeks before the starting assessment
• People who had major surgery or radiation therapy within 4 weeks before the starting assessment
• People who took part in another clinical trial using an experimental treatment within 4 weeks before the starting assessment
• People who take certain medications that interact with a protein called P-glycoprotein or a related transporter (BCRP), unless those medications can reliably be taken at least 3 hours apart from the trial drug (confirm with trial site)
• People whose cirrhosis is rated as Child-Pugh Class A, B8/9, or C (confirm with trial site for exact scoring details)
• People who have a condition called hepatic encephalopathy (confusion or other brain-related symptoms caused by liver disease)
• People who have had bleeding in the oesophagus or digestive tract requiring a blood transfusion within 4 weeks before the starting assessment
• People with a thyroid condition that is not well controlled, as assessed by the trial's principal investigator
• People with an active bacterial, viral, or fungal infection that requires systemic treatment or a procedure to treat it
• People with a known HIV or AIDS-related illness
• People who have had a liver transplant
• People who have another active cancer in addition to liver cancer
• People with uncontrolled high blood pressure or severe heart failure (classified as New York Heart Association Class 3 or 4)
• People who have experienced chest pain (angina), heart attack, stroke, bypass surgery, mini-stroke (TIA), or blood clot in the lungs within 3 months before starting the trial drug
• People with a history of, or current, heart rhythm problems requiring treatment, any grade of atrial fibrillation, or a persistently abnormal heart electrical interval measurement (QTc above 470 msec) — though people with a specific heart conduction issue called bundle branch block are not excluded for this reason alone
• Women who are pregnant or breastfeeding
• Women who could become pregnant, unless they agree to use two forms of contraception considered effective by the investigator while on the trial drug
• Men whose partner could become pregnant, unless they agree to use two forms of contraception (including a condom) while on the trial drug and for 3 months afterward
• People with any serious medical or psychiatric condition, or significantly abnormal test results, that in the investigator's opinion could make trial participation unsafe, interfere with consent or cooperation, or affect the reliability of trial results

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