Phase 1 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) confirmed by a tissue or cell sample
• People whose liver cancer is locally advanced or on the borderline of being surgically removable, meeting at least one of these descriptions: a single tumour larger than 5 cm; multiple tumours in one side of the liver (more than 3 tumours, or at least one larger than 3 cm); tumours in both sides of the liver where enough healthy liver would remain after surgery; or a tumour larger than 3 cm with signs of blood vessel involvement or a high AFP protein level (above 400)
• People whose cancer has not spread outside the liver, has not reached the lymph nodes, has not involved both the left and right branches of the main liver vein (portal vein), and has not grown into the main vein draining the liver (hepatic vein or IVC) — involvement of one hepatic vein branch does not automatically exclude someone (confirm with trial site)
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1)
• People aged 18 years or older at the time of consent
• People with a good general health and activity level (ECOG performance status of 0 or 1, meaning fully active or able to carry out light activity)
• People whose blood counts and organ function meet minimum levels, including: haemoglobin, white blood cell count, and platelets within required ranges; liver function, bilirubin, albumin, and clotting levels within required ranges; and kidney function at an adequate level — these must be met without recent blood transfusions, infusions, or growth factor treatments in the 14 days before starting the trial

Who may not be able to join:

• People who have previously received systemic (whole-body) treatment for liver cancer
• People who have had radiation therapy covering more than 30% of their bone marrow, or wide-field radiation, within the 28 days before starting the trial
• People who have needed a procedure to drain fluid from the abdomen (paracentesis) within 6 weeks before the first scheduled dose
• People who have had active bleeding from stomach or oesophageal varices (swollen veins), stomach ulcers, or upper gastrointestinal bleeding within 60 days before joining — people with a history of variceal bleeding or who are considered high risk may need to have had appropriate treatment before being considered (confirm with trial site)
• People who have experienced a episode of hepatic encephalopathy (a condition where the liver cannot filter toxins, affecting brain function) within the 12 months before joining
• People who currently have uncontrolled high blood pressure (diastolic above 90 mmHg or systolic above 140 mmHg)
• People who have previously had external beam radiation to the liver, or a liver-directed radiation treatment called yttrium-90 radioembolization
• People with a high hepatitis B viral load (above 100 IU/mL), people taking corticosteroid medication at more than 10 mg prednisone daily, or people with an active autoimmune disease that has required systemic treatment in the past 2 years
• People whose tumour has grown directly into the stomach, duodenum, or bowel
• People with active or untreated cancer spread to the brain or the lining of the brain and spinal cord
• People with a history of another cancer, unless it was treated with curative intent with no known active disease for at least 5 years and carries a low risk of returning; or was a non-melanoma skin cancer or certain early-stage skin condition that has been adequately treated with no signs of disease; or was a carcinoma in situ adequately treated with no signs of disease
• People diagnosed with specific rare subtypes of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, or mixed liver and bile duct cancer
• People with an active infection including tuberculosis or HIV

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