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 aged 18 or older
• People who have been diagnosed through laboratory testing with colorectal cancer (a type of bowel cancer) that has spread to other parts of the body and cannot be removed by surgery
• People whose advanced, spread cancer has not yet been treated with any systemic (whole-body) anti-cancer medicines
• People who previously received cancer treatment before or after surgery (neoadjuvant or adjuvant therapy) where the cancer was first found to have come back at least 12 months after that earlier treatment ended
• People who have at least one measurable tumour that can be tracked using standard imaging guidelines (RECIST v1.1)
• People with a good general level of physical functioning, as measured by a standard medical scale (ECOG score of 0 or 1 — confirm with trial site)
• People with normal bone marrow and organ function based on test results
• People (or their legal representatives) who understand the study and voluntarily agree to take part by signing a consent form

Who may not be able to join:

• People whose cancer has a specific genetic feature (known as MSI-H or dMMR) and who the doctor considers suitable for a type of treatment called immune checkpoint inhibitors
• People with a known allergy to the study drug or any of its ingredients
• People who are underweight, with a body mass index (BMI) below 18.5 kg/m²
• People with known or suspected cancer spread to the brain or central nervous system
• People who have previously received a chemotherapy drug called irinotecan
• People who have had surgery or other cancer treatments within the 4 weeks before joining the trial
• People who still have side effects from previous cancer treatment that have not recovered to a mild level or resolved (as defined by a standard medical grading system — confirm with trial site)
• People who are taking certain medicines that affect how the body processes drugs (CYP3A, CYP2C8, or UGT1A1 inhibitors or inducers) and where stopping these medicines within 2 weeks before joining is not possible or has not been done
• People with serious digestive or gastrointestinal disorders
• People with a lung condition called interstitial lung disease
• People who have had a significant arterial blood clot or major bleeding episode in the 6 months before joining (not counting bleeding related to planned surgery)
• People with fluid build-up in the body that cannot be kept stable (note: small amounts of fluid around the lungs or abdomen seen on scans but causing no symptoms may still be eligible — confirm with trial site)
• People with a bowel blockage (intestinal obstruction) or a high short-term risk of developing one
• People with a hole in the digestive tract (gastrointestinal perforation), an abscess in the abdomen, or an abnormal channel connecting organs (fistula)
• People with any serious or uncontrolled ongoing illness, such as uncontrolled high blood pressure, significant heart disease, active uncontrolled bleeding, or active serious viral infection
• People who have had another type of cancer in the past 5 years or currently have one, except for certain cancers that have been fully cured (such as some cervical, uterine, or non-melanoma skin cancers — confirm with trial site)
• People of childbearing potential who are unwilling to use contraception, and people who are pregnant or breastfeeding
• People the trial doctors consider unsuitable for participation for any other reason

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