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, or HCC) that cannot be removed with surgery or treated with a liver transplant, and who are planned to receive radiation therapy along with the medicines atezolizumab and bevacizumab. Tumours must meet specific size limits (no single tumour larger than 15 cm, and the total size of all tumours combined less than 20 cm).
• People whose liver cancer diagnosis has been confirmed either by a tissue/cell sample test, or by a specific pattern seen on a CT or MRI scan.
• People aged 18 or older at the time of signing the consent form.
• People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage B (Intermediate) or stage C (Advanced) (confirm with trial site).
• People whose liver function has been assessed and scored 5 or 6 on the Child-Pugh scale within 28 days before joining the study, indicating relatively well-preserved liver function (confirm with trial site).
• People who have had blood tests confirming their hepatitis B virus (HBV) status.
• People who have had blood tests confirming their hepatitis C virus (HCV) status.
• People who are willing and able to understand and sign a written consent form.
• People whose blood, liver, and kidney test results fall within the required ranges within 4 weeks before joining the study, including adequate levels of red blood cells, white blood cells, platelets, and acceptable liver and kidney function markers (confirm with trial site for specific values).
• People whose medical team, experienced in liver cancer care, has assessed that the benefits of the combined radiation and drug treatment outweigh the risks.

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 received radiation therapy to the liver area in a way that would overlap with the radiation fields planned for this trial.
• People who have previously received a type of internal radiation treatment to the liver using yttrium (also called selective internal radiotherapy or hepatic arterial yttrium therapy), at any point in the past.
• People who have untreated or active hepatitis B or hepatitis C infection.
• People who have moderate to severe or difficult-to-control fluid build-up in the abdomen (ascites).
• People whose cancer has spread to distant parts of the body (distant metastases).
• People who have untreated or incompletely treated swollen 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 IV antibiotics in the past 28 days; any bleeding episode in the past 6 months; clot-dissolving (thrombolytic) therapy in the past 28 days; a known bleeding or clotting disorder; or an uncontrolled psychiatric condition.
• People who are pregnant, or people who could become pregnant or father a child and are not willing or able to use medically acceptable contraception during the trial.
• People who have previously had a solid organ transplant (such as a kidney, heart, or lung transplant).
• People who have or have had an autoimmune disease, such as autoimmune hepatitis, inflammatory bowel disease, lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions.
• People who have or have had blood clotting or bleeding disorders, coughing up blood, stroke, significant heart disease, or a hole (perforation) in the stomach or bowel.
• People for whom radiation therapy cannot be used to treat all areas of disease — for example, those with cancer that has spread outside the liver, or whose liver tumours are too large to be safely covered by radiation within safe dose limits.
• People known to have HIV infection.
• People who are unable to have an MRI scan, including those with certain metal implants in the brain, a cardiac pacemaker, a cochlear implant, or severe claustrophobia.
• People with certain medical conditions that may cause problems during an MRI scan, such as active infections, uncontrolled heart or breathing problems, mental health conditions affecting cooperation, or diarrhoea.
• People whose recent endoscopy (within the past 6 months) showed a high risk of upper gastrointestinal bleeding, and who have not yet completed treatment to prevent it.
• People who are allergic to hyperpolarized 13C pyruvate, atezolizumab, bevacizumab, or any of their ingredients.

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