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:

• A diagnosis of liver cancer (hepatocellular carcinoma) confirmed by tissue sample or by meeting recognised medical diagnostic guidelines for this type of cancer.
• Adults aged 18 or older.
• Fully active and able to carry out normal daily activities without any restriction (a specific performance score of 0 on a standard medical scale).
• No previous systemic cancer treatments or arterial-based liver procedures for this liver cancer.
• Liver cancer that has been assessed as a mid-stage (BCLC stage B) that is not suitable for surgery or local treatment, with a tumour burden above a specific threshold called the "Up-To-Seven" criteria, cancer spread across both sides of the liver with multiple tumours, at least one tumour visible and measurable on a CT or MRI scan, no blood clot in the main liver vein, and no spread of cancer outside the liver.
• No signs of dangerous variceal bleeding risk, confirmed by scan or scope examination within the past 6 months showing no enlarged veins in the food pipe or stomach and no active ulcers.
• Liver function rated as Child-Pugh A (a measure of how well the liver is working).
• Blood counts within acceptable ranges: platelets, white blood cells, and neutrophils all above specific minimum levels.
• Liver-related blood test results (bilirubin and liver enzymes) within acceptable ranges.
• No fluid build-up in the abdomen, normal blood clotting, and a blood protein (albumin) level at or above a minimum threshold.
• Kidney function blood test results within an acceptable range.
• A life expectancy of more than 3 months.

Who may not be able to join:

• People with specific rare subtypes of liver cancer, including fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or bile duct carcinoma.
• People with a history of brain complications from liver disease (hepatic encephalopathy) or a previous liver transplant.
• People with fluid around the lungs, in the abdomen, or around the heart that is causing symptoms and requires draining.
• People with active hepatitis B or C infection where virus levels in the blood are above specific thresholds, or those who test positive for both hepatitis B and hepatitis C markers — though people whose virus levels have dropped below these thresholds through antiviral treatment may still be considered (confirm with trial site).
• People who have experienced certain serious heart or blood vessel events in the past 12 months, including heart attack, severe chest pain, heart bypass surgery, heart failure, stroke, or blood clots in the lungs; or who currently have an irregular heartbeat of a certain severity, an abnormally long heart rhythm measurement on an ECG, or high blood pressure that cannot be controlled with medication.
• People who require kidney dialysis, or who have severe failure of other major organs.
• People who have had a different cancer diagnosed within the past 3 years, except for certain low-risk cancers that have been fully treated (such as early-stage cervical, skin, prostate, breast, or uterine cancers with very high survival rates).
• People with cancer that has spread to the brain or the lining of the brain.
• People with bleeding disorders, haemophilia, or those taking high-dose blood-thinning medications such as warfarin-type drugs.
• Women who are pregnant or breastfeeding; women of childbearing age must have a negative pregnancy test within 7 days before enrolling.
• People with a history of any organ transplant.
• People with a known HIV infection.
• People with active tuberculosis.
• People with known allergies to chemotherapy drugs used in this trial.
• People with other serious ongoing physical or mental health conditions that, in the medical team's judgement, would make participation unsafe or affect the reliability of study results.
• People with an active autoimmune disease or a history of one, including conditions such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, autoimmune hepatitis, and a range of other immune system disorders.
• People with other serious physical or mental health conditions, or abnormal test results, that the medical team considers would make participation unsafe or interfere with the study.
• People with a history of not following medical treatment plans, or those who are unable to give informed consent in a reliable way.

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