Phase 2 Colorectal 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 who have colorectal cancer (a specific type called adenocarcinoma) that has spread to the liver, where the liver tumours are either unable to be surgically removed (Group A) or can be completely surgically removed (Group B), and where cancer has not clearly spread to other parts of the body — with limited exceptions for certain nearby lymph nodes and up to 5 lung spots that have been stable or shrinking for at least 2 months on chemotherapy and can be treated with targeted radiation or surgery
• People who have a confirmed diagnosis of a type of bile duct cancer inside the liver (intrahepatic cholangiocarcinoma) that cannot be surgically removed (Group C), where less than 70% of the liver is affected and the cancer has not clearly spread beyond the liver — again with limited exceptions for certain nearby lymph nodes
• People aged 18 or older
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard medical fitness scale (ECOG score of 0 or 1)
• People whose recent blood test results (taken within 14 days before joining) meet specific levels for white blood cells, liver function, platelets, kidney function, haemoglobin, and blood clotting (confirm specific values with trial site)
• People living with HIV who are on effective treatment and have had an undetectable level of virus in the blood within the past 6 months
• People with a history of chronic hepatitis B who are on suppressive treatment and have an undetectable virus level in the blood
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on hepatitis C treatment with an undetectable virus level
• People who have previously received chemotherapy, as long as the last dose was given at least 3 weeks before joining the trial
• People who have previously received another experimental treatment, as long as the last dose was given at least 3 months before joining the trial
• People who wish to choose the at-home monitoring option (CO arm) must be able to attend video appointments using a computer, tablet, or smartphone with internet or mobile network access

Who may not be able to join:

• People whose cancer has clearly spread to distant parts of the body beyond the liver (with limited exceptions for certain nearby lymph nodes and, for colorectal cancer only, up to 5 stable or shrinking lung spots treatable with targeted radiation or surgery)
• People whose cancer has a specific genetic feature called microsatellite instability (MSI) or mismatch repair deficiency (MMR-D)
• People who have previously had radiation treatment to the liver in any form (note: prior radiation to the pelvis is generally acceptable)
• People who are currently taking or have recently taken a medication called bevacizumab (Avastin) — a minimum 6-week gap from the last dose is required before joining
• People who have an active infection or a condition called hepatic encephalopathy (a brain-affecting complication of liver disease)
• People with clinical signs of high blood pressure in the liver's portal vein system, such as fluid build-up in the abdomen (ascites unrelated to surgery), swollen veins in the oesophagus, or a blood clot in the portal vein
• People who are pregnant, breastfeeding, or planning to become pregnant within 6 months after finishing treatment — women of childbearing potential must have a negative pregnancy test before surgery
• People whom the treating doctor considers to have serious medical conditions that would make this type of treatment unsafe
• People with a history of brain or spinal cord tumours, poorly controlled seizures, or a stroke within the past 3 months (or with significant lasting effects from a previous stroke, at the doctor's discretion)
• People with a serious or non-healing wound, ulcer, or bone fracture
• People with a past or current separate cancer that could interfere with the safety or effectiveness of the trial treatment
• People with psychiatric conditions or personal circumstances that the trial team believes would make it difficult to follow the study requirements — such as active severe substance or alcohol use
• People who cannot reliably commit to travelling to the trial site (either Lexington, KY for one treatment option, or a local site for another) every 2 weeks for approximately 6 months, and who do not have dependable transport in all weather conditions
• People with certain internal stents (such as AXIOS™ stents) used after gastric bypass surgery may or may not be eligible, depending on the treating doctor's assessment of whether the stent can be safely managed around the trial procedure (confirm with trial site)

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