Phase 2 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 to 75 years old (any gender)
• People who have been diagnosed with colorectal cancer confirmed by laboratory tissue or cell testing, with advanced cancer that has spread and cannot be treated with surgery (stage IV)
• People who have at least one tumour that can be measured on a CT scan, meeting specific size requirements
• People whose cancer has stopped responding to, or who could not tolerate, a first- or second-line chemotherapy treatment containing oxaliplatin
• People with a good general level of physical functioning (rated 0 or 1 on a standard activity scale used by doctors)
• People with an expected survival of at least 3 months
• People whose major organs (blood, liver, kidneys, heart, etc.) are functioning within acceptable levels based on blood and urine tests taken within 14 days before the first dose
• People who have finished any previous cancer treatments at least 4 weeks before joining, and whose side effects from those treatments have mostly resolved
• Women of childbearing age who test negative for pregnancy within 7 days before starting the trial, are not breastfeeding, and agree to use an approved form of contraception throughout the trial; male participants whose partners can become pregnant must also agree to use approved contraception throughout the trial
• People who are willing to take part and sign a consent form, and who are able to follow the trial visit schedule and requirements

Who may not be able to join:

• People who have had another type of cancer (other than colorectal cancer) within the past 5 years, with some exceptions for certain low-risk or localised cancers (confirm with trial site)
• People whose tumour is known to have certain genetic features (called dMMR or MSI-H) that suggest they may be better suited to a different type of treatment called immunotherapy
• People whose tumour has a specific genetic change called BRAF V600E mutation, which is associated with a poorer response to chemotherapy
• People with cancer that has spread to the brain or central nervous system, or where this has not been ruled out by a recent scan (within 28 days before the first dose)
• People who have previously received chemotherapy containing irinotecan or irinotecan liposome
• People who have taken certain medications that strongly affect how the liver processes drugs (CYP3A4, CYP2C8, or UGT1A1 inhibitors or inducers) within 14 days before starting the trial
• People who have taken part in another clinical drug trial within 4 weeks before the first dose
• People with serious bowel problems, such as bleeding, blockage, significant inflammation, or ongoing diarrhoea above a certain severity
• People with serious other health conditions that could interfere with treatment, including: severe heart or blood vessel disease, uncontrolled diabetes or high blood pressure, uncontrolled infection, active stomach ulcers, a blood clot or stroke event within the past year, tumours growing near major blood vessels in a way that could cause severe bleeding, certain autoimmune diseases (such as lupus or autoimmune hepatitis), active tuberculosis, previous or current lung inflammation (interstitial lung disease or non-infectious pneumonia requiring steroids), the need for ongoing high-dose steroid or immunosuppressive treatment, poorly controlled heart failure or irregular heartbeat, positive test results for hepatitis C or HIV, a serious infection within the past 4 weeks, or nerve damage in the hands or feet rated grade 2 or higher
• People with a known allergy or intolerance to any of the study drugs (irinotecan hydrochloride liposome injection, 5-FU/LV, or bevacizumab) or their ingredients
• People with a known medical reason why they cannot take any of the study drugs
• Women who are pregnant, breastfeeding, or have recently given birth and are unwilling to use contraception
• People whom the treating doctor believes should be excluded for other medical, psychological, or safety-related reasons (confirm with trial site)

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