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 over 18 and up to 75 years old, of any gender, who have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC) either confirmed by tissue testing or by meeting recognised medical diagnostic guidelines.
• People whose liver cancer is classified as BCLC stage C without spread to distant parts of the body or lymph nodes, or BCLC stage B where surgery to remove the cancer is not possible (confirm with trial site if unsure of your stage).
• People who have at least one tumour that can be measured on a scan, meeting specific size requirements under a standard measurement system called RECIST 1.1.
• People who have not previously received any systemic (whole-body) cancer treatment, and whose target tumours have not previously been treated with local procedures such as embolisation, ablation, surgery, or radiotherapy.
• People with a liver function score (Child-Pugh score) below 7, indicating reasonably well-functioning liver.
• People with a physical performance score (ECOG PS) of 0 or 1, meaning they are fully active or have only minor limitations in daily activity.
• People whose doctors expect them to survive for more than 12 weeks.
• Women who have not been surgically sterilised and are pre-menopausal must have a negative pregnancy test within 7 days before joining, must not be breastfeeding, and must agree to use medically approved contraception during treatment and for 3 months after.
• Men who have not been surgically sterilised must agree to use medically approved contraception with their female partners during treatment and for 3 months after.
• People whose blood counts, liver function, kidney function, and clotting results meet specific minimum levels as measured by blood tests (confirm details with trial site).

Who may not be able to join:

• People whose liver cancer has been confirmed as a specific rare type, such as fibrolamellar HCC, sarcomatoid HCC, or bile duct cancer (cholangiocarcinoma).
• People who have previously received any local or whole-body cancer treatment.
• People with a history of a condition called hepatic encephalopathy (a brain complication from liver disease).
• People who have previously had a liver transplant.
• People with significant fluid build-up around the heart requiring drainage, or symptomatic fluid around the lungs.
• People with noticeable fluid build-up in the abdomen (ascites) that can be detected on physical examination or that has needed draining.
• People who have both hepatitis B and hepatitis C infections at the same time.
• People with cancer that has spread to the brain or the lining around the brain or spinal cord.
• People who have had bleeding from oesophageal or stomach varices (enlarged veins caused by liver-related high blood pressure) in the 6 months before joining, or who have severe varices found on a scope examination of the upper digestive tract.
• People who have had a significant bleeding event (Grade 3 or above) in the 4 weeks before joining, or who have a known tendency to bleed.
• People who have had a serious blood clot event — such as a heart attack, stroke, pulmonary embolism, or deep vein thrombosis — in the 6 months before joining (routine clots related to medical port devices may not apply — confirm with trial site).
• People with high blood pressure that cannot be controlled with medication, or a history of hypertensive crisis or related brain complications.
• People with moderate to severe heart failure, or a heart pumping function (ejection fraction) below 50% on an echocardiogram.
• People with poorly controlled heart rhythm problems, a history of a condition called long QT syndrome, or certain abnormal heart rhythm measurements on an ECG.
• People with a history of heart muscle inflammation or disease, or dangerous heart rhythm disorders.
• People with serious clotting or bleeding disorders, or who are currently receiving clot-dissolving (thrombolytic) therapy.
• People currently taking high-dose aspirin (more than 325 mg per day) or blood-thinning medications that require INR monitoring (such as warfarin) within 10 days before starting the trial.
• People with a history of gastrointestinal perforation, bowel obstruction, extensive bowel removal, Crohn's disease, ulcerative colitis, or long-term chronic diarrhoea in the 6 months before joining.
• People who received radiation therapy within 3 weeks before joining (those who received it more than 7 days before may be considered — confirm with trial site).
• People with current or past interstitial lung disease, or lung disease that has required steroid treatment.
• People with active tuberculosis, currently receiving TB treatment, or who have received TB treatment in the past year.
• People with an active autoimmune disease or a history of autoimmune conditions (such as autoimmune hepatitis, inflammatory lung or bowel conditions, kidney inflammation, or thyroid disease requiring surgery). People with childhood asthma that has fully resolved and needs no treatment may still be eligible; those with asthma requiring ongoing medication may not be.
• People who have been using immune-suppressing medications, including steroids at doses above the equivalent of 10 mg per day of prednisone, within the 2 weeks before enrolling.
• People with an active infection or unexplained fever above 38.5°C at the time of screening or within 4 weeks before joining (unless the fever is considered by the doctor to be caused by the tumour itself).
• People with evidence of lung scarring, radiation-related lung damage, drug-related lung damage, or severely reduced lung function.
• People with HIV infection or other conditions that cause a weakened immune system.
• People who have received a live vaccine within 4 weeks before starting the study, or who may need a live vaccine during the study.
• People with a known history of alcohol, drug, or substance misuse.
• People who are unable to take medication by mouth.
• People who, in the treating doctor's judgement, have other serious conditions (including significant mental health conditions), severe digestive tract varices, major abnormal test results, or personal or social circumstances that could affect their safety or the reliability of the study data.

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