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 doctors have determined cannot be treated with 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 under 20 cm).
• People whose liver cancer diagnosis has been confirmed either by a tissue or 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 fully active or able to carry out light work (ECOG performance status 0–1).
• People whose liver cancer is classified as intermediate (Stage B) or advanced (Stage C) using the Barcelona Clinic Liver Cancer (BCLC) staging system.
• People whose liver is functioning at a level rated 5–6 on the Child-Pugh scoring system, confirmed within 28 days before joining the study.
• 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 sign a written consent form.
• People whose blood, liver, and kidney function results fall within the required ranges in the 4 weeks before joining the study (the trial site can confirm the specific values).

Who may not be able to join:

• People who have had another type of cancer in the past, unless they have been cancer-free for at least 2 years.
• People who have previously had radiation treatment to the liver area in a way that would overlap with the new radiation fields planned in this trial.
• People who have ever had a type of internal radiation treatment to the liver using yttrium (also called selective internal radiotherapy or hepatic arterial yttrium therapy).
• People with hepatitis B or hepatitis C that is currently active and has not been treated.
• People with moderate to severe fluid build-up in the abdomen (ascites) that cannot be controlled.
• People whose cancer has spread to distant parts of the body in a way that cannot be covered by proton radiation therapy.
• People with 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 last 6 months; a heart attack in the last 6 months; a serious bacterial or fungal infection requiring IV antibiotics in the last 28 days; any bleeding episode in the last 6 months; clot-dissolving (thrombolytic) therapy in the last 28 days; a known bleeding or clotting disorder; or an uncontrolled psychotic disorder.
• People who are pregnant, or people of childbearing potential or sexually active men who are not willing or able to use medically accepted contraception.
• People who have previously had a solid organ transplant.
• People who have, or have previously had, an autoimmune disease (such as autoimmune hepatitis, lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions — the trial site can provide a full list).
• People who have, or have previously had, serious blood clotting or bleeding disorders, coughing up blood, stroke, significant heart disease, or a hole (perforation) in the stomach or intestines.
• People whose cancer cannot be fully covered and treated by proton radiation therapy (for example, due to cancer spread outside the liver, or tumours so large that safe radiation limits for the liver cannot be met).
• People known to be living with HIV.

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