Phase 3 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:

• Adults aged 18 to 75 years old
• People who have been diagnosed with colorectal cancer (a type of bowel cancer) confirmed through laboratory testing of tissue samples
• People whose cancer has spread to the liver, with no more than 5 spots (lesions) in the liver, confirmed by scans
• People whose cancer has specific genetic characteristics — described as RAS wild-type, BRAF wild-type, and pMMR/MSS — confirmed by genetic or laboratory tests
• People who have no cancer spread outside the liver, confirmed by CT, MRI, or PET/CT scans
• People whose original bowel tumour has already been removed or can be fully removed with surgery
• People whose liver spots are suitable for complete removal or treatment (through surgery, heat-based ablation, or targeted radiation), with no cancer expected to remain afterwards, and enough healthy liver tissue remaining after treatment
• People who have not yet received any anti-cancer treatment directed at the liver metastases (previous surgery to remove the original bowel tumour is allowed)
• People with healthy enough blood cell counts — specifically, platelets, white blood cells, and neutrophils all above certain minimum levels
• People with liver blood test results within acceptable ranges, no fluid build-up in the abdomen, normal blood clotting, and adequate protein levels in the blood
• People with liver function rated as Child-Pugh grade A (a medical rating indicating the liver is functioning well) (confirm with trial site)
• People with kidney function within normal range, either by blood test or by a calculated kidney function score above 50 ml/min
• People with a general health and activity level rated as ECOG 0 or 1, meaning fully active or able to carry out light activity (confirm with trial site)
• People with a life expectancy of more than 3 months
• People who have signed a written consent form agreeing to take part
• People who are willing and able to attend follow-up appointments until the end of the study or until they pass away

Who may not be able to join:

• People whose colorectal cancer has spread to parts of the body other than the liver
• People who have already received chemotherapy, targeted therapy, interventional procedures, or immunotherapy aimed at their liver metastases
• People for whom surgical treatment of the liver spots is not planned
• People who received a chemotherapy regimen containing oxaliplatin within the past year
• People who still have significant side effects from previous chemotherapy (other than hair loss), such as nerve-related symptoms rated at grade 2 or above on a standard medical scale
• People who used immune-suppressing medications in the week before starting the study treatment (except for certain low-dose or locally applied steroids, or steroids used to prevent allergic reactions to contrast dye)
• People with a lung condition called interstitial lung disease that requires steroid treatment
• People with a known active autoimmune disease currently needing treatment, or who have had such a disease requiring treatment in the past 2 years — though some specific conditions with no need for systemic treatment in the past 2 years may still be eligible (confirm with trial site)
• People with a known history of a primary immune system deficiency
• People with active tuberculosis
• People who have previously received an organ transplant or a bone marrow/stem cell transplant from a donor
• People with a known allergy to any monoclonal antibody or to the chemotherapy drugs used in this trial (fluorouracil or oxaliplatin) or to their ingredients
• People with a tendency to bleed or a blood clotting disorder
• People with significant symptoms of a blocked bowel
• People who have had a severe spike in blood pressure (hypertensive crisis) or blood-pressure-related brain swelling
• People with severe uncontrolled health complications such as serious infection or uncontrolled diabetes
• People with serious heart or blood vessel conditions, including stroke or heart attack within the past 6 months, uncontrolled high blood pressure, unstable chest pain, significant heart failure, or an irregular heartbeat requiring medication
• People with a history of, or current, central nervous system conditions such as a brain tumour, uncontrolled epilepsy, any history of cancer spreading to the brain, or a history of stroke
• People diagnosed with another cancer in the past 5 years (except certain skin cancers or cervical cancer in situ that have been fully treated)
• People who have taken part in another clinical drug trial within the past 28 days
• Women who are pregnant or breastfeeding, women of childbearing age who are not using or are unwilling to use effective non-hormonal contraception, or men who are able to father children and are unwilling or unable to follow the study's requirements in this regard

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