Phase 3 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 been diagnosed with colorectal cancer (a type of bowel cancer) that has spread to other parts of the body or come back, and cannot be removed by surgery — confirmed by lab testing of tissue samples
• People whose doctors estimate they are likely to live for at least 12 weeks
• People who have not yet received any drug treatments (such as chemotherapy) for their metastatic (spread) colorectal cancer
• People who previously received treatment before or after surgery (neoadjuvant or adjuvant therapy), where that treatment finished more than 12 months before the cancer came back or got worse
• People who have at least one measurable area of cancer that has not been treated with radiation (or, if it was previously in a radiated area, where the cancer has been confirmed to have grown)
• People who are willing to provide previously collected tumour tissue, or agree to have a tissue sample (biopsy) taken, for genetic testing
• People who are in reasonably good physical condition — able to carry out light activity and look after themselves — as measured by a standard medical scoring scale (ECOG score of 0 or 1), checked within 7 days before the first dose
• People whose major organs (such as kidneys, liver, and bone marrow) are functioning well enough, based on test results

Who may not be able to join:

• People whose colorectal cancer has a specific genetic feature called MSI-H (confirmed by gene testing)
• People whose cancer has spread only to the liver in a limited way, and where surgery to remove it may be possible
• People whose cancer has spread to the brain or the lining around the brain or spinal cord
• People who have had radiation therapy within the past 6 months (with some exceptions for short-course radiation to bones for pain relief, given at least 14 days before the study starts — confirm with trial site)
• People with a history of, or current, certain lung conditions such as interstitial pneumonia, dust-related lung disease, radiation damage to the lungs, or drug-related lung inflammation, or any condition that could make it hard to detect lung side effects from study drugs
• People who have had major surgery within 28 days before joining — defined as surgery needing at least 3 weeks of recovery
• People who have previously had an intestinal stent placed that is still in position at the time of screening
• People with blood pressure that remains too high despite medical treatment (specifically, systolic pressure of 150 mmHg or above, and/or diastolic pressure of 100 mmHg or above)
• People who have a history of a severe high blood pressure crisis or high blood pressure affecting the brain
• People who have had a significant or severe bleeding episode within the past month, or received a blood transfusion within the past 2 weeks
• People who need to take anti-inflammatory pain medicines (such as ibuprofen or naproxen) every day on a long-term basis
• People who have evidence of severe, unexplained abdominal bloating or gas build-up (confirm with trial site)
• People with serious wounds that have not healed, open skin splits, active ulcers, or untreated broken bones
• People who have experienced any of the following within the past 6 months: a fistula (abnormal passage) in the abdomen or food pipe, a hole in the gut, an abscess inside the abdomen, or large amounts of fluid in the abdomen needing drainage or treatment; blockage of the bowel or ongoing signs of bowel obstruction; severe uncontrolled inflammation inside the abdomen; or major blood vessel disease such as a large artery aneurysm or recent blood clots in limb arteries

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