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:

• People who have been diagnosed with liver cancer (hepatocellular carcinoma/HCC) that has been assessed as not suitable for surgery or a liver transplant, with tumours meeting specific size limits (no single tumour larger than 15 cm, and the total size of all tumours less than 20 cm combined).
• People whose liver cancer diagnosis has been confirmed either by a tissue or cell sample test, or by specific scan findings on a CT or MRI.
• People aged 18 or older at the time of signing the consent form.
• People whose general health and ability to carry out daily activities falls within a certain range (ECOG performance status 0–1, meaning fully active or able to carry out light activity — confirm with trial site).
• People whose liver cancer is at an intermediate or advanced stage according to the Barcelona Clinic Liver Cancer (BCLC) staging system — stages B or C.
• People whose liver is functioning within a certain range, measured by a Child-Pugh score of 5 or 6, assessed within 28 days before joining the study.
• People who have had their hepatitis B virus (HBV) status confirmed through a blood test.
• People who have had their hepatitis C virus (HCV) status confirmed through a blood test.
• People who are able to understand the study and are willing to sign a written consent form.
• People whose blood counts, liver function, and kidney function fall within acceptable ranges on tests done within 4 weeks before joining, including: haemoglobin at least 9.0 g/dL; neutrophil count at least 1,000/mm³; platelets at least 50,000/μL; bilirubin below 2.5 mg/dL; albumin above 2.8 g/dL; certain liver enzymes (ALT and AST) no more than 3 times the normal upper limit; blood clotting time within a certain range; and creatinine (a kidney marker) no more than 1.5 mg/dL.

Who may not be able to join:

• People who have had another type of cancer in the past, unless they have been free of that cancer for at least 2 years.
• People who have previously had radiation treatment to the liver area in a way that would overlap with the planned new treatment field.
• People who have previously had a type of internal radiation treatment using yttrium delivered to the liver (also called SIRT or hepatic arterial yttrium therapy), at any point in the past.
• People who have untreated or currently active hepatitis B or hepatitis C.
• People who have a moderate to severe or difficult-to-control build-up of fluid in the abdomen (ascites).
• People whose cancer has spread to distant parts of the body in a way that cannot be treated with the proton radiation therapy used in this trial.
• People who have untreated or incompletely treated enlarged veins in the oesophagus or stomach (varices).
• People with serious, active health conditions, including: unstable chest pain or heart failure requiring hospitalisation in the past 6 months; a heart attack in the past 6 months; a serious bacterial or fungal infection requiring intravenous antibiotics in the past 28 days; any bleeding episode in the past 6 months; clot-dissolving (thrombolytic) treatment in the past 28 days; a known bleeding or clotting disorder; or an uncontrolled psychotic disorder.
• People who are pregnant, or women who could become pregnant and are not willing or able to use medically acceptable contraception, and men who are sexually active and not willing or able to use contraception.
• People who have previously had a solid organ transplant (such as a kidney, heart, or liver transplant).
• People who have or have had an autoimmune disease — conditions where the immune system attacks the body — such as autoimmune hepatitis, inflammatory bowel disease, lupus, rheumatoid arthritis, multiple sclerosis, or several other related conditions.
• People who have or have had blood clotting or bleeding disorders, coughing up of blood, a stroke, significant heart disease, or a hole or tear in the gastrointestinal tract.
• People for whom it is not possible to treat all areas of their cancer using proton radiation therapy (for example, if cancer has spread outside the liver, or if liver tumours are so large that safe radiation limits cannot be met).
• People who have a known HIV infection.

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