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 who have agreed to take part and have signed a consent form, and who are willing and able to attend scheduled visits and follow the study plan
• People aged 18 years or older, of any gender
• People whose colorectal cancer has been confirmed by a pathology test and is at an advanced stage (no other cancer types are included)
• People with colorectal cancer who have already received at least two rounds of systemic cancer treatment, including chemotherapy with an irinotecan-based regimen and/or targeted therapy
• People who have at least one tumour that can be measured in a standard way on scans, according to established guidelines (called RECIST 1.1)
• People who are reasonably active and able to care for themselves, based on a standard performance scale scored at 0 or 1 (confirm with trial site)
• People whose doctors estimate they are likely to live for at least 3 more months
• People whose major organs — including blood, liver, kidneys, and heart — are working well enough to meet specific blood test and imaging standards set by the trial
• People who are able to use medically approved contraception during the study and for 6 months after it ends, and who test negative for pregnancy within 7 days before joining, and who are not breastfeeding (for those who could potentially become pregnant); male participants who are not surgically sterile must also agree to use contraception during the study and for 6 months afterward

Who may not be able to join:

• People who have had or currently have another cancer, except for certain cured skin cancers (basal cell carcinoma) or early-stage cervical cancer that has been treated
• People who have taken part in another clinical drug trial within the 4 weeks before enrolling
• People with serious problems affecting the digestive system, such as bleeding, blockage, significant inflammation (above a certain severity level), or diarrhoea above a mild level
• People who have experienced a hole in the gut, a gut fistula (abnormal connection), an abdominal abscess, or a non-gut fistula (such as between the windpipe and oesophagus) within the 6 months before enrolling
• People who have fluid build-up in the abdomen (ascites) that requires drainage with a needle
• People with a large build-up of fluid in the chest (such as pleural effusion) that has not been stable for at least 2 weeks before enrolling
• People with signs of gastrointestinal bleeding, including active ulcers, strongly positive stool blood tests, or a history of black stools or vomiting blood within the past 2 months
• People known to have interstitial lung disease that is more than just an incidental finding on imaging
• People known to have cancer that has spread to the brain or spinal cord (central nervous system), or who have a history of this; people suspected of having this must have appropriate scans within 28 days before enrolling to rule it out
• People who have been taking certain medications that strongly affect how the body processes drugs (strong CYP3A4, CYP2C8, or UGT1A1 inhibitors or inducers) within 2 weeks before enrolling (confirm with trial site)
• People with high blood pressure that cannot be controlled with a single blood pressure medication, a history of unstable chest pain (angina), a new angina diagnosis within the past 3 months, a heart attack within the past 6 months, certain heart rhythm problems, or heart failure of a certain severity
• People known to be allergic to any ingredient in the study drugs, including irinotecan liposomes, bevacizumab, or cetuximab, or other liposome products
• People with abnormal blood clotting or a tendency to bleed; people taking blood-thinning medications such as warfarin, heparin, or similar drugs (low-dose warfarin up to 1 mg daily or low-dose aspirin up to 100 mg daily may be allowed under certain conditions — confirm with trial site)
• Women of childbearing age who refuse to use approved contraception during the study and for 6 months after, who test positive for pregnancy within 7 days before enrolling, or who are currently breastfeeding; male participants who are not surgically sterile and refuse to use approved contraception during and for 6 months after the study
• People with active hepatitis B or hepatitis C at certain levels, known HIV/AIDS, or active syphilis
• People with an active infection, an unexplained fever of 38.5°C or above in the week before enrolling, or a high white blood cell count during screening; people who have taken antibiotic treatment (not preventive) by mouth or drip within 2 weeks before enrolling
• People with a known history of neurological or psychiatric conditions, including epilepsy or dementia
• People whose doctors assess them as having other health conditions that could pose serious risks during the trial or prevent them from completing it
• People whom the researchers determine may be unsuitable for other reasons that could affect the study's progress or results

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