Phase 3 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 are willing and able to sign a written consent form agreeing to take part
• People who are older than 18 and younger than 70 years of age
• People who have been diagnosed with a specific type of rectal cancer (adenocarcinoma) confirmed by tissue testing, located within 12 cm of the anal opening
• People whose general health and ability to carry out daily activities is rated as good or only mildly limited (ECOG score of 0 or 1)
• People whose pelvic MRI scan shows the cancer is locally advanced and high-risk, meaning it has grown into or near the surrounding tissue lining, spread to nearby structures, or involves certain lymph nodes nearby
• People who have not previously received any systemic cancer treatment for colorectal cancer, including chemotherapy, immunotherapy, or targeted or hormonal medicines
• People whose blood test results show adequate bone marrow, liver, and kidney function (tested within 7 days before starting the study treatment)
• People who are willing and able to follow the study schedule and attend all required visits

Who may not be able to join:

• People whose scans (CT, MRI, or PET-CT) show the cancer has spread to distant parts of the body
• People who have had a different type of cancer in the past 5 years (other than colorectal cancer)
• People who have a complete blockage of the bowel, active bleeding, or a tear in the bowel that requires emergency surgery
• People whose cancer has grown into the small intestine, or who have an abnormal passage (fistula) between the rectum and another organ, or a pocket of infection (abscess) in the area
• People who have another active cancer, unless it was fully treated with the intention of cure and has been in remission for more than 5 years, or was a very early-stage non-invasive cancer that was adequately treated
• People who have previously had radiotherapy to the pelvis, or who have received any cancer treatment within the 12 months before joining the study
• People who have had a blood clot-related event within the past 12 months, such as a stroke, mini-stroke, blood clot in the lungs, or blood clot in a deep vein
• People who have had a heart attack, severe chest pain, significant heart rhythm problems, or serious heart failure within the past 12 months
• People whose tumour has been tested and found to have specific genetic features known as dMMR or MSI-High
• People who are currently taking, or have taken within the past 2 weeks, blood-thinning medicines at high doses or certain antiplatelet medications
• People who have had major surgery or serious physical injury within the past 2 months (a colostomy before joining may be acceptable if the wound has fully healed — confirm with trial site)
• People with a known history of HIV infection or AIDS
• People who have lung disease such as interstitial lung disease or non-infectious lung inflammation, or uncontrolled ongoing conditions such as uncontrolled diabetes, uncontrolled high blood pressure, pulmonary fibrosis, active pneumonia, aneurysm, or blood clotting disorders
• People with untreated active hepatitis B or C, or a co-infection with both hepatitis B and C viruses, based on blood test results
• People who are known to be allergic to the study medicines or any of their ingredients
• People who are pregnant or breastfeeding
• People who have any other serious physical or mental health condition, or abnormal test results, that the trial doctor believes could make participation unsafe or affect the study results

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