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 aged 18 or older at the time of signing the consent form
• People who have a confirmed diagnosis of liver cancer (HCC) through a tissue or cell sample test
• People whose liver cancer is classified as BCLC Stage C, or BCLC Stage B that cannot be treated with local tumour-targeting procedures
• People whose liver function is rated as Child-Pugh A (a measure of how well the liver is working)
• People who are reasonably active and able to care for themselves, rated 0 or 1 on a standard health performance scale
• People whose cancer has continued to grow or spread after one previous systemic (whole-body) treatment for liver cancer that cannot be surgically removed
• People who have at least one tumour that can be measured using standard imaging guidelines (RECIST v1.1)
• People whose kidneys, blood counts, and liver function meet the required levels for this trial
• People who have recovered from side effects of previous treatments to a mild or stable level
• People with hepatitis B or C infection, provided the infection is being managed according to local medical practice (antiviral treatment is permitted)
• People who have previously had treatment for varicose veins in the stomach or food pipe (varices), provided there has been no significant bleeding
• Women who could become pregnant must have a negative pregnancy blood test within 48 hours before the first dose, and must agree to use a barrier method plus a second highly effective form of contraception
• Men who are sexually active must use a condom during intercourse, and those whose partners could become pregnant must also agree to a second highly effective form of contraception — this includes men who have had a vasectomy

Who may not be able to join:

• People who have a specific rare subtype of liver cancer, including fibrolamellar carcinoma, sarcomatoid HCC, or combined hepatocellular cholangiocarcinoma
• People who have previously had a liver transplant
• People with a known allergy or sensitivity to the study drugs (RYZ811 or RYZ801) or their ingredients
• People whose liver cancer has extensively blocked a major blood vessel to the liver (portal vein tumour thrombosis classified as Vp4)
• People who have experienced confusion or brain problems caused by liver disease (hepatic encephalopathy) within the past 6 months
• People who have had a clinically significant build-up of fluid in the abdomen (ascites) within the past 6 months
• People who have had external radiation therapy to the liver within the past 12 weeks
• People who have previously had radioembolisation (a type of internal radiation treatment) to the liver
• People who have had brain or spinal cord (CNS) metastases that have been treated but have not yet recovered from the acute side effects
• People with a documented history of certain serious lung conditions, including pulmonary fibrosis, interstitial lung disease, or inflammation of the lungs (pneumonitis)
• People with certain uncontrolled health conditions, including an abnormal heart rhythm measurement (QTcF greater than 470 ms), poorly controlled blood sugar (HbA1c of 8% or more), uncontrolled high blood pressure, significant heart disease or heart failure, or a history of clinically significant bleeding
• People in the dose expansion part of the trial who have previously been treated with lenvatinib (confirm with trial site)
• People who have previously taken part in any other interventional clinical study
• People with a current physical or mental health condition that may interfere with the study
• People who have had another type of cancer in the past 3 years, with some exceptions (confirm with trial site for details)
• People who, in the opinion of the treating doctor, would be better suited to a different treatment
• People who are pregnant or breastfeeding

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