Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from the 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 or older
• People who have been diagnosed with colorectal cancer (a type of bowel cancer) confirmed by a tissue test showing it is an adenocarcinoma (a specific cancer cell type)
• People whose cancer started on the left side of the colon or rectum and has spread to other parts of the body
• People whose cancer initially had a specific gene change called a RAS mutation, and did not have a BRAF gene change
• People whose cancer got worse after two standard rounds of chemotherapy treatment, including drugs from the fluorouracil, oxaliplatin, and irinotecan families
• People whose cancer got worse during or within 3 months of a treatment that included irinotecan
• People whose blood test (checking cancer DNA in the blood) shows that both the RAS and BRAF genes have returned to their normal (unchanged) state after the second round of chemotherapy stopped working
• People who have at least one area of cancer that can be clearly measured on a scan, according to standard medical guidelines
• People with blood counts within acceptable ranges — including platelets, white blood cells, neutrophils (infection-fighting cells), and haemoglobin (a measure of red blood cell health)
• People with liver and kidney function within acceptable ranges based on blood test results
• People with good liver health, rated as Class A on a standard liver scoring system
• People with a general health and activity level rated 0, 1, or 2 on a standard scale used by doctors (meaning someone who is fully active to someone who can care for themselves but cannot do physical work)
• People with a life expectancy of more than 3 months
• People who are willing and able to sign a consent form agreeing to take part
• People who are willing and able to be followed up by the study team until the end of the study or until they pass away

Who may not be able to join:

• People whose cancer started on the right side of the colon or rectum
• People whose cancer has a specific feature called dMMR or MSI-H (a marker related to how the cancer repairs its DNA)
• People whose cancer did not have a RAS gene change at the start, or who did have a BRAF gene change at the start
• People whose blood test after second-line treatment shows the cancer still has a RAS or BRAF gene change
• People with serious blood clots in arteries or a significant build-up of fluid in the abdomen
• People with serious bleeding problems or blood clotting disorders
• People with serious uncontrolled health conditions such as major infections or uncontrolled diabetes
• People with significant heart or blood vessel problems, including a stroke or heart attack in the past 6 months, uncontrolled high blood pressure despite treatment, unstable chest pain, heart failure, or a heart rhythm problem requiring medication
• People with a history of brain or nervous system conditions, such as a brain tumour, epilepsy not controlled by standard treatment, any previous cancer spread to the brain, or a history of stroke
• People who have had another type of cancer in the past 5 years, with the exception of certain skin cancers, a specific type of cervical pre-cancer, or thyroid cancer that was fully removed by surgery
• People who have had an allergic reaction to any of the drugs being used in the study
• People who are pregnant or breastfeeding
• Women who could still become pregnant (defined as less than 2 years since their last menstrual period) or men who could father a child, who are not willing to use effective non-hormonal contraception (such as an IUD, barrier methods with spermicide, or surgical sterilisation)
• People who are unable or unwilling to follow the study procedures
• People with other health conditions, complications from cancer spread, or concerns found during a physical examination that a doctor determines could make participation unsafe or unsuitable (confirm with trial site)

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