Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from the 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 has been assessed as not suitable for surgery or liver transplant, with tumours confirmed either by tissue biopsy or by specific patterns seen on CT or MRI scans.
• People whose liver cancer involves one or more tumours, where no single tumour is larger than 15 cm and the total size of all tumours combined is less than 20 cm.
• People aged 18 or older at the time of signing the consent form.
• People who are generally well enough to carry out light activity and care for themselves, with only mild limitations (this is measured using a scale called ECOG performance status 0–1).
• People whose liver cancer is classified as intermediate (Stage B) or advanced (Stage C) using a system called the Barcelona Clinic Liver Cancer (BCLC) staging system.
• People whose liver is functioning at a specific level, measured within 28 days of joining the study using a scoring system called the Child-Pugh score, with a score of 5 or 6.
• 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 willing and able to understand and sign a written consent form.
• People whose blood, liver, and kidney results fall within the required ranges when tested within 4 weeks before joining the study, including:
  • Haemoglobin (a measure of red blood cells) of at least 9.0 g/dL
  • A white blood cell type called neutrophils at a count of at least 1,000/mm³
  • Platelets (cells that help with clotting) at least 50,000/μL
  • A liver waste product called bilirubin below 2.5 mg/dL
  • A blood protein called albumin above 2.8 g/dL
  • Two liver enzymes (ALT and AST) no more than 3 times the upper limit of the normal range
  • Blood clotting time not more than 6 seconds longer than normal
  • A kidney function marker called creatinine at or below 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 therapy to the liver area in a way that would overlap with the radiation fields used in this trial.
• People who have ever received a type of internal radiation treatment to the liver using a substance called yttrium (also known as selective internal radiotherapy or hepatic arterial yttrium therapy).
• People who have active hepatitis B or hepatitis C that has not been treated.
• 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 photon radiation therapy.
• People who have untreated or incompletely treated enlarged veins in the oesophagus or stomach (varices).
• People with serious active health conditions, including any of the following:
  • Unstable chest pain or heart failure that required hospitalisation in the last 6 months
  • A heart attack in the last 6 months
  • A serious bacterial or fungal infection requiring intravenous antibiotics in the last 28 days
  • Any significant bleeding episode in the last 6 months
  • Treatment with clot-dissolving medication in the last 28 days
  • A known disorder affecting bleeding or blood clotting
  • An uncontrolled psychotic disorder
• People who are pregnant, or women who could become pregnant and men who are sexually active and are not willing or able to use an accepted form of 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 — a condition where the immune system attacks the body — including conditions such as autoimmune hepatitis, inflammatory bowel disease, lupus, rheumatoid arthritis, multiple sclerosis, and several others (confirm with trial site for the full list).
• People whose cancer cannot be fully treated with photon radiation therapy, for example because of tumours outside the liver or because the liver tumours are too large to be safely covered by radiation.
• People with a known HIV infection.

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