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 diagnosed with colorectal cancer that has spread only to the liver and cannot be surgically removed.
• People whose cancer has not visibly spread outside the liver (though small, stable lung nodules under 6mm may be acceptable — confirm with trial site).
• People whose original bowel tumour may still be in place.
• People who have completed 3–6 months of a first standard chemotherapy treatment for their colorectal cancer, or who developed new liver metastases within 12 months of finishing chemotherapy given after earlier-stage colorectal cancer surgery.
• People whose cancer was stable or responding during that first chemotherapy course.
• People whose liver cancer cannot be safely removed surgically because doing so would leave too little healthy liver tissue, or would require removal of major blood vessels — confirmed by a specialist medical team.
• People who have had a CT scan of the chest, abdomen, and pelvis within 4 weeks before joining, to check suitability for the procedure and rule out cancer spread outside the liver.
• People considered generally well enough to undergo surgery, with a performance status rating of 0 or 1 on a standard medical scale (meaning mostly or fully active in daily life).
• People whose recent blood test results (taken within 14 days before joining) show adequate levels of white blood cells, platelets, liver function, and kidney function within acceptable ranges.
• People with a history of another cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial.
• People living with HIV who are on effective treatment and had an undetectable viral load within the 6 months before joining (HIV testing is not required to apply).

Who may not be able to join:

• People whose liver tumours take up more than 70% of the total liver volume.
• People who have previously had radiation treatment directed at the liver (prior pelvic radiation completed at least 2 weeks before joining may be acceptable — confirm with trial site).
• People who have previously had certain liver-directed procedures, including bland embolisation, chemoembolisation (TACE), or radioembolisation (TARE).
• People who have previously been treated with a hepatic arterial infusion (HAI) pump or the chemotherapy drug floxuridine (FUDR).
• People whose colorectal cancer has a specific genetic feature called microsatellite instability-high (MSI-H).
• People whose liver metastases could potentially be removed through a two-stage surgical approach (including a technique called ALPPS).
• People with an active infection, or a wound, ulcer, or bone fracture that is not healing.
• People with serious medical conditions that would make it unsafe to receive the trial treatments or prevent full participation in the trial.
• People with liver cirrhosis or signs of increased pressure in the liver's blood supply (portal hypertension).
• People who are pregnant or breastfeeding. People who could become pregnant must have a negative pregnancy test within 14 days before joining.
• People who are not willing or able to use effective contraception or abstain from sexual intercourse for the duration of the trial, to avoid pregnancy or fathering a child during treatment.

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