Phase 3 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 been diagnosed with colorectal cancer (bowel cancer) that has been confirmed by a tissue biopsy and has spread to other parts of the body.
• People whose cancer responded well to a first round of treatment that included a type of drug called an anti-EGFR therapy — meaning the cancer either shrank significantly, or stayed stable for at least 6 months.
• People whose cancer has since started growing again after that first treatment.
• People whose cancer has been tested on tissue samples and shown to have no changes (mutations) in the RAS or BRAF genes.
• People whose cancer has also been tested through a blood test and shown to have no certain gene mutations (in RAS, BRAF, PIK3CA, EGFR ECD) and no HER2 amplification at the time of joining the trial.
• People whose cancer can be measured on scans, using standard medical measurement guidelines.
• People aged 18 or older.
• People who are generally well enough to carry out daily activities with no or only minor limitations (as assessed by the trial doctor using a standard scale).
• People whose blood test results, taken within 14 days before starting treatment, show that bone marrow, liver, and kidney function are all within acceptable ranges as defined by the trial.
• Women who could become pregnant must have a negative pregnancy test taken within 7 days before starting the trial treatment.
• People who agree to use effective contraception throughout the trial and for at least 6 months after the last dose of treatment, as agreed with the trial doctor.
• People who have read and signed a consent form before any screening begins.

Who may not be able to join:

• People who have a medical reason why they cannot take any of the drugs used in this trial (cetuximab, bevacizumab, irinotecan, 5-FU, oxaliplatin, or folic acid).
• People with an active infection that is not under control, a serious blood-clotting disorder, or a history of a lung condition called interstitial lung disease.
• People who have had another type of cancer in the past or present, unless it was a fully treated skin cancer (basal or squamous cell) or a very early-stage cervical condition that was successfully treated.
• People who are currently pregnant.
• People who are currently breastfeeding.
• Women who could still become pregnant, or men who could father a child, who are not willing to use effective contraception.
• People who have had a heart attack, unstable chest pain, or a certain type of heart procedure (balloon angioplasty, with or without a stent) in the past 12 months, or who have severe heart failure.
• People who have heart rhythm problems that require medication to control, unless the only medication they take for this is a beta blocker or digoxin.
• People whose medical or psychological condition would make it difficult for them to understand and agree to participate, or to complete the trial.
• People who have taken part in another clinical trial or received an experimental treatment within the 30 days before joining this trial.
• People with known or suspected cancer that has spread to the brain.
• People with a history of bowel blockage, chronic inflammatory bowel disease, or ongoing diarrhoea.
• People with serious wounds, ulcers, or bone fractures that are not healing.
• People with a significant kidney condition involving high levels of protein in the urine (nephrotic syndrome).
• People known to have a deficiency in an enzyme called DPD (which affects how certain chemotherapy drugs are processed by the body).
• People with a known history of alcohol or drug misuse.
• People with another serious health condition that, in the trial doctor's opinion, would make participation unsafe or unsuitable.
• People who do not have the legal capacity to consent to participation.
• People whose tumour has a specific genetic profile (known as dMMR or MSI-H) and who are eligible for an approved immunotherapy treatment — unless that treatment is not suitable for them or they have chosen not to have it (confirm with trial site).

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