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:

• You are willing to receive treatment before surgery (called neoadjuvant therapy).
• You are 18 years old or older.
• Your tumor is located in the rectum, no more than 12 cm from the opening of the anus, confirmed by physical exam, colonoscopy, and MRI scan.
• Your cancer has been confirmed by a tissue sample (biopsy) to be a type called rectal adenocarcinoma.
• Your cancer is at a certain stage based on CT and MRI scans — broadly meaning it has spread to nearby lymph nodes, or the tumor has grown to a certain size without spreading to lymph nodes (confirm with trial site for exact staging details).
• A test on your cancer tissue has shown a specific genetic profile called "pMMR" or "MSS" (meaning your cancer does not have a certain type of genetic instability).
• You are able to attend follow-up appointments at the hospital as required.
• Your general health and ability to carry out daily activities scores well on a standard medical scale (ECOG score of 0 or 1, meaning you are fully active or have only minor limitations).
• You have not previously received any anti-cancer or immunotherapy treatments.
• Your blood, liver, kidney, and clotting test results meet the required levels set by the trial (confirm with trial site for specific values).
• You are willing to take part voluntarily and sign a consent form.

Who may not be able to join:

• You have been diagnosed with another type of cancer in the past 5 years.
• Your cancer has spread to other parts of the body (stage IV).
• Your cancer staging falls outside the required range — for example, very early stage or a specific locally advanced stage — or you have affected lymph nodes in certain areas near the pelvis (confirm with trial site for details).
• You currently need emergency surgery due to a blocked, perforated, or bleeding bowel.
• You have a known allergy to any of the trial drugs, including oxaliplatin, capecitabine, or a type of immunotherapy drug called a PD-L1 monoclonal antibody.
• Your biopsy shows a specific cancer cell type called signet ring cell carcinoma or mucinous adenocarcinoma.
• Your cancer tissue shows the genetic profile "dMMR" or "MSI-H" (a type of genetic instability).
• You have a serious uncontrolled medical condition, such as severe infection, uncontrolled diabetes, uncontrolled high blood pressure, heart problems, or significant liver, kidney, or metabolic disease.
• You have a mental health condition, alcohol dependency, or drug misuse that could make it difficult to safely take part in the trial or could affect the results.
• You have an active autoimmune disease (where your immune system attacks your own body) that could get worse with immunotherapy treatment.
• You are known to be HIV-positive or have AIDS.
• You are currently taking immune-suppressing medications, with some limited exceptions for low-dose steroids used in specific ways (confirm with trial site for details).
• You have taken part in another clinical trial or received an experimental drug within the 30 days before screening.
• You are pregnant, breastfeeding, planning to become pregnant during the study, or you (or your partner) are unwilling to use effective contraception during the study.
• You are considered part of a vulnerable group, such as those with serious cognitive impairment, critical illness, or are a minor.
• The trial doctors have another reason to believe participation would not be appropriate for you.

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