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:

• You have been diagnosed with rectal cancer (confirmed by a tissue sample) that has not come back after previous treatment, and the tumor is located within 12 cm of the opening of the back passage.
• Your cancer is at a specific stage (T3-4 N0 or TX N+), as shown by MRI and PET-CT scans.
• Your doctors have planned a specific treatment approach called "total neoadjuvant therapy" (TNT) and consider you a candidate for surgery.
• You have not had any previous chemotherapy, immunotherapy, radiation therapy, or surgery for rectal cancer.
• You have never had radiation therapy to the pelvis area for any reason.
• You are able to provide a tissue sample (from your colonoscopy) for testing and research purposes.
• You are 18 years old or older.
• You are reasonably active and able to care for yourself (your doctor will assess this using a standard scale).
• Your blood test results meet certain minimum levels for white blood cells, platelets, hemoglobin, kidney function, and liver function (the trial team will check these).
• You are able to swallow tablets.
• If you are able to have children, you agree to use a highly effective form of contraception during the study and for at least 9 months after the last chemotherapy dose and 120 days after the last immunotherapy dose.
• If you are a woman who could become pregnant, you must have a negative pregnancy blood test within 7 days before starting treatment.
• You are not currently breastfeeding.
• You are willing and able to sign a consent form and attend all required visits, treatments, and tests.

Who may not be able to join:

• You have an active autoimmune disease, or a history of one — with exceptions for type 1 diabetes, an underactive thyroid treated with hormones only, or mild skin conditions (such as vitiligo, psoriasis, or hair loss) that do not need systemic treatment.
• You have a history of vasculitis (inflammation of the blood vessels).
• You have previously had an organ transplant, including a bone marrow transplant from a donor.
• You have more than mild nerve damage causing numbness or tingling in your hands or feet.
• You have previously been treated with certain types of immunotherapy drugs that target immune checkpoints (such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or similar treatments).
• You have had another cancer within the last 2 years, unless it was a localised cancer that was fully treated and cured (for example, certain skin cancers, early bladder cancer, or early-stage cervical or breast cancer).
• You have a serious, uncontrolled medical condition or active infection that your doctor feels could make participation unsafe or affect your ability to complete the treatment.
• You have a known positive HIV test result or have been diagnosed with AIDS.
• You have a known active hepatitis B or hepatitis C infection, or a history of hepatitis B or C with detectable levels of the virus in your blood.

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