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:

• People aged 18 or older
• People who have been diagnosed with colorectal cancer that has been confirmed by a tissue sample (biopsy)
• People whose colorectal cancer has spread to the liver in a way that cannot be surgically removed (based on a CT scan done within 4 weeks before joining the trial)
• People who have no cancer spread outside the liver, or who have only very small lesions (10mm or smaller) outside the liver that are not clearly cancerous
• People who have not previously received any systemic (whole-body) treatment for their colorectal cancer
• People whose liver blood supply is suitable for placement of a special chemotherapy delivery catheter (a small tube inserted into an artery near the liver) — the treating team will assess this based on scans
• People with an ECOG performance status of 0 or 1, meaning they are fully active or have only mild limitations in physical activity
• People expected to live for at least 12 weeks
• People whose cancer has been tested and has a known RAS and BRAF mutation status
• People whose original (primary) bowel tumour is still in place and can be surgically removed without needing pre-surgery treatment
• People who are medically suitable for surgery
• People who are medically suitable for a two-drug chemotherapy combination
• People whose recent blood tests (taken within 15 days before joining) show that their bone marrow, liver, and kidneys are functioning at an adequate level, based on specific thresholds for blood counts, liver enzymes, and kidney function (confirm exact values with the trial site)
• People who have given written informed consent before joining

Who may not be able to join:

• People who have previously had radiation treatment, surgery, or ablation (tissue destruction) on the liver
• People with another illness, cancer-related condition, or other health problem that the treating doctor believes would interfere with the trial treatment or with the outlook for liver metastases
• People with a history of another cancer, unless: it was treated with the intent to cure and there has been no evidence of active disease in the past 3 years; or it is considered low-risk for return by the treating team; or it is a well-controlled non-melanoma skin cancer; or it is a treated carcinoma in situ with no current signs of disease
• People whose primary bowel tumour is causing a blockage that needs emergency surgery, requires removal of multiple surrounding organs, requires a specific type of surgery called abdominoperineal resection, or is a rectal tumour needing pre-surgery radiotherapy or chemotherapy-plus-radiotherapy
• People whose cancer has a specific genetic feature called MMR deficiency (a DNA repair problem)
• People with a deficiency of an enzyme called DPD, which affects how certain chemotherapy drugs are broken down by the body
• People who are pregnant or breastfeeding
• People with serious other health conditions that could put them at risk or prevent them from completing the trial, as judged by the treating doctor
• People who have received an organ transplant and require immunosuppressant medications
• People with a serious wound, ulcer, or bone fracture that has not healed
• People taking ongoing corticosteroid medication at a dose of 10mg per day or more of methylprednisolone (or an equivalent), not including inhaled steroids
• People with serious active or uncontrolled infections
• People with a significant psychiatric history that the investigator believes would prevent them from giving informed consent or following the trial treatment plan
• People with psychological, family, social, or geographic circumstances that could make it difficult to follow the trial schedule and requirements
• People with an existing liver disease, including liver scarring (fibrosis) or cirrhosis

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