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:

• People who have fully understood the study, agreed to take part, and signed a consent form.
• People aged 18 to 70 years old.
• People who are generally well enough to carry out daily activities with little or no limitation (as rated by a standard medical scale called ECOG, with a score of 0 or 1).
• People whose expected survival is at least 12 weeks.
• People who have been diagnosed with a specific type of colon or upper rectal cancer (called MSS/pMMR-type adenocarcinoma) that has been confirmed by tissue testing and cannot be treated with radiotherapy.
• People whose cancer has been assessed by scans and a specialist team discussion as either potentially removable with surgery involving nearby organs, or not fully removable by surgery.
• People whose cancer is at a specific stage (cT4N1-2M0 or cT4bN0M0 according to a standard staging system) — confirm the exact meaning with the trial site.
• People with more than one colorectal cancer tumour, as long as at least one of those tumours meets the other criteria listed here.
• People who had a bowel blockage that has already been relieved by a stent or a surgical opening (ostomy).
• People who have not previously received any treatment for this cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• People who have at least one tumour that can be measured on scans using a standard method.
• People whose blood and organ function test results meet all of the following: haemoglobin of at least 90 g/L; white blood cell count of at least 3.5×10⁹/L; neutrophil count of at least 1.5×10⁹/L; platelet count of at least 100×10⁹/L; kidney function within a normal or near-normal range; bilirubin (a liver marker) no more than 1.5 times the upper limit of normal; two liver enzyme levels (AST and ALT) no more than 2.5 times the upper limit of normal.
• People who are able to become pregnant or who can father children, and who are willing to use effective contraception during the trial and for six months after the last treatment.

Who may not be able to join:

• People who have had a serious allergic reaction to any of the study drugs or to similar liposomal medications.
• People who have taken part in another clinical trial within the past 4 weeks.
• People who have been diagnosed with another cancer within the past 5 years (with some exceptions, such as certain treated skin cancers or cervical changes that were fully cured, or other cancers fully treated more than 5 years ago with no signs of return).
• People whose colorectal cancer is of the dMMR/MSI-H type (a different molecular subtype).
• People who have nerve damage in their hands or feet that is already causing noticeable symptoms (grade 2 or higher on a standard medical scale).
• People who are unable to swallow, have a problem with their upper digestive tract that affects absorbing food or medication, or cannot take oral medication.
• People who experienced serious bleeding within the past 4 weeks.
• People who had an abdominal fistula, a hole in the bowel, a bowel blockage, ongoing diarrhoea, or inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) within the 6 months before joining the trial.
• People who have active interstitial lung disease with symptoms (those with scan findings only and no symptoms may still be eligible — confirm with trial site).
• People who have uncontrolled spread of cancer to the brain or spinal cord, or certain other conditions affecting the central nervous system.
• People who have taken certain specific medications that affect how the body processes drugs (strong inhibitors or inducers of CYP3A4 and CYP2C8, or strong inhibitors of UGT1A1) within the past 2 weeks — confirm the specific medications with the trial site.
• People with high blood pressure that is not controlled by one blood pressure medication, or with significant heart problems such as poor heart pumping function, heart failure, severe or unstable chest pain, a stroke or mini-stroke or heart attack within the past 6 months, or certain heart rhythm problems.
• People with abnormal blood clotting, a tendency to bleed, or who are currently receiving blood-thinning or clot-dissolving treatment.
• People who are able to become pregnant or father children but are not willing to use contraception.
• People with active hepatitis B, hepatitis C, syphilis, or HIV infection.
• People who have an active infection currently requiring treatment within 2 weeks of starting the trial.
• People with a confirmed history of a neurological or mental health condition, including epilepsy or dementia.
• People with any other significant illness, metabolic condition, or abnormal test results that the trial doctor considers would make participation unsafe or affect the study results.

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