Phase 1 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 between 18 and 75 years old, of any gender
• People who are well enough to carry out daily activities with little or no limitation (based on a standard fitness scale used by doctors, scored 0 or 1)
• People who have been confirmed through a biopsy to have a specific type of rectal cancer (called pMMR rectal adenocarcinoma) located in the lower part of the rectum, within 10 cm of the opening of the anus, that has not spread to distant parts of the body
• People whose cancer has at least one of the following features that make it higher risk: cancer that has grown into surrounding tissue or spread to nearby lymph nodes in certain ways, cancer affecting nearby blood or lymph vessels, cancer close to an important boundary in the pelvis, spread to side lymph nodes, or a situation where surgery to preserve the bowel opening (sphincter) may not be possible (confirm with trial site for exact definitions)
• People whose chest and abdomen scans show the cancer has not spread to distant parts of the body
• People whose bone marrow is producing enough blood cells, based on specific blood test results (neutrophils, platelets, and haemoglobin levels within required ranges)
• People whose liver is working well enough, based on specific blood test results for liver enzymes, bilirubin, and protein levels
• People whose kidneys are working well enough, based on specific blood test results for creatinine or kidney filtration rate
• Women and people who could become pregnant must have a negative pregnancy test within 72 hours before starting treatment, and must agree to avoid pregnancy during treatment and for 6 months after treatment ends; men who could father a child must agree to use approved contraception during treatment and for 90 days after the final treatment
• People who agree to receive the chemotherapy treatment used in this study before surgery and who sign a consent form confirming they understand and agree to participate

Who may not be able to join:

• People who have had another type of cancer in the past 5 years, unless it was a type that has been fully treated and has not come back (such as certain skin cancers or early-stage cancers that stayed in one place)
• People who have an active infection — bacterial, viral, or fungal — that is not being controlled despite receiving appropriate treatment
• People who have serious uncontrolled health conditions, including unstable heart problems (such as angina, heart attack, heart failure, or severe irregular heartbeat), uncontrolled high blood pressure despite medication, a history of hypertensive crisis, or uncontrolled diabetes (confirm with trial site for exact definitions)
• People who are known to be allergic or sensitive to any of the drugs or ingredients used in this study's treatment
• People who have any medical signs that would make chemotherapy or surgery unsafe for them (confirm with trial site)
• People who are currently taking certain strong medications that affect how the body processes drugs (specifically strong inhibitors or inducers of enzymes called CYP3A4, CYP2C8, and UGT1A1)
• Women who are pregnant or breastfeeding, or women who could become pregnant and are unwilling to use appropriate contraception during the study
• People who have taken part in another clinical trial within the 4 weeks before joining this study
• People the trial doctors consider unsuitable for participation for any other reason

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