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:

• Your colorectal cancer spread to the liver (liver metastases) and was surgically removed with the goal of curing you, but you could not receive a specific chemotherapy drug called oxaliplatin before or around the time of surgery, either for medical reasons or because you could not tolerate it
• Your liver metastases appeared more than 12 months after your original colorectal cancer was treated
• No more than 10 liver spots were treated during your surgery
• You received at least 2 but no more than 8 rounds of a chemotherapy regimen called FOLFIRI (with or without a targeted therapy drug) before your surgery
• Your pre-surgery chemotherapy finished no more than 12 weeks before your operation
• Your surgery successfully removed all visible cancer from the liver (with or without a heat-based treatment called radiofrequency ablation), leaving no visible disease behind
• Your cancer showed a positive response to the chemotherapy given before surgery, either seen on scans or confirmed by examining the removed tissue
• Scans taken within 6 weeks after surgery show no cancer remaining in the liver or elsewhere in the body (a single small, unclear lung spot smaller than 10mm does not count as spread)
• Your colorectal cancer tissue has been tested to identify specific gene changes (RAS and BRAF status)
• You are 18 years of age or older
• You are generally well enough to carry out light activity and care for yourself (this is measured on a standard scale called WHO performance status 0 or 1)
• You are covered by a social security (health insurance) scheme

Who may not be able to join:

• Your liver surgery was only aimed at reducing cancer rather than curing it, or some visible cancer was left behind after surgery
• 10 or more liver spots were treated at the time of surgery
• You only had radiofrequency ablation (heat treatment) on all liver spots, with no surgical removal of tissue
• There is cancer present outside the liver or cancer remaining in the liver
• Your cancer did not respond to the chemotherapy given before surgery (no improvement seen on scans or in removed tissue)
• You have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
• You carry two copies of a specific gene variant called UGT1A1*28, which affects how your body processes certain drugs (confirm with trial site)
• You have a complete absence of an enzyme called DPD, which helps your body break down certain chemotherapy drugs — shown by a specific blood test result (confirm with trial site)
• You have a medical reason why you cannot take the chemotherapy drugs used in this trial (irinotecan, 5-FU, or folinic acid) or the supporting medications (ondansetron or methylprednisolone)
• You are still experiencing side effects from your pre-surgery chemotherapy that have not fully resolved
• You are pregnant, breastfeeding, or a pregnancy test shows you may be pregnant

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