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:

• You have been diagnosed with an advanced or spreading solid tumor cancer that has been confirmed by a tissue sample (biopsy).
• You are generally able to care for yourself and carry out daily activities, even if you cannot do heavy physical work (based on a standard doctor's rating scale).
• Your blood counts (red blood cells, white blood cells, and platelets) are at acceptable levels without needing recent blood transfusions or growth factor injections.
• Your kidneys are working well enough, based on a standard calculation using your blood test results.
• For people with normal liver function: Your liver test results (bilirubin and a liver enzyme called AST) are within or close to the normal range.
• For people with moderate liver problems: Your bilirubin level is moderately elevated (above normal but within a specific range), and your liver is not functioning at full capacity.
• For people with moderate liver problems and a condition called hepatic encephalopathy (brain confusion caused by liver disease): Your doctor believes you are still able to understand and agree to take part in the trial.

Who may not be able to join:

• You have difficulty with blood draws due to poor veins.
• You have donated or lost 500 mL or more of blood recently, or plan to do so during the study.
• You have received a biological cancer treatment within the last 4 weeks, or chemotherapy, targeted therapy, or radiation within the last 2 weeks, and have not fully recovered from the side effects.
• You have received a specific chemotherapy drug called irinotecan within the last 4 weeks.
• You have not yet recovered from side effects of a previous cancer treatment.
• You currently have a second active cancer.
• You have active cancer that has spread to the brain or the lining around the brain, unless the brain cancer was previously treated, has been stable for at least 4 weeks, all symptoms have gone back to normal, there are no new or growing brain tumors, and you are taking only a low dose of steroids (below a certain level).
• You have a history of heart disease.
• You have active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease) or had a hole in your digestive tract (bowel perforation) within the last 6 months.
• You currently have a serious active infection (confirm with trial site).
• You have taken high-dose steroid tablets or injections in the last 2 weeks (note: steroid inhalers, nasal sprays, joint injections, or skin creams are generally allowed).
• You are currently taking certain medications that strongly affect how a particular liver enzyme (UGT1A1) works (confirm with trial site which medications apply).
• You have a known condition called Gilbert's disease (a mild inherited liver condition).
• For people with normal liver function: You have a pre-existing condition that significantly affects how your liver or kidneys process medications.
• For people with moderate liver problems: Your liver disease symptoms (such as stomach pain, nausea, vomiting, loss of appetite, or fever) got significantly worse in the 2 weeks before starting the study.
• For people with moderate liver problems: You have a severe build-up of fluid in your abdomen (called tense ascites).
• For people with moderate liver problems: You had signs of an active viral hepatitis infection within the last month.
• For people with moderate liver problems: You have a condition where your liver disease is also causing your kidneys to fail (called hepatorenal syndrome).
• For people with moderate liver problems: You have had a specific procedure to redirect blood flow in your liver (called a TIPS procedure).
• For people with moderate liver problems: You have severe brain confusion caused by liver disease (Stage 3 or 4 encephalopathy).

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