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:

• People who are willing and able to sign a written consent form agreeing to take part.
• Adults aged 18 to 75 years old.
• People who have been confirmed through a tissue or cell sample test to have a type of rectal cancer called adenocarcinoma.
• People who have not previously had any systemic (whole-body) cancer treatment for their rectal cancer.
• People whose tumor is located within 10 centimetres of the opening of the back passage.
• People whose cancer has been assessed by MRI scan and found to be at a certain stage (specific staging categories involving spread to nearby lymph nodes but not to distant parts of the body, and without involvement of a specific boundary around the rectum) — confirm exact staging details with the trial site.
• People whose primary tumor can be seen on a CT or MRI scan.
• People who are in reasonably good general health and able to carry out daily activities with little or no difficulty (as rated by a standard medical scale called ECOG, scoring 0 or 1).
• People who have a suitable tumor tissue sample available for testing to check a specific genetic feature (MSI/MMR status).
• People who test negative for the Hepatitis B surface antigen (a marker for active Hepatitis B infection).
• People who test positive for Hepatitis B surface antigen but have a very low level of Hepatitis B virus in their blood (below a specific threshold — confirm with trial site).
• People who test negative for Hepatitis C antibody or have no detectable Hepatitis C virus in their blood, or people who do have detectable Hepatitis C virus but have liver enzyme levels (ALT and AST) within an acceptable range (confirm with trial site).

Who may not be able to join:

• People who have had rectal cancer come back after previous treatment, or who have previously had radiation therapy to the pelvic area.
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• People who have HIV (including those who test positive for HIV1, HIV2, or HTLV1 antibodies) or AIDS-related illnesses.
• People who are preparing for, or have previously had, an organ or bone marrow transplant.
• People who have had a heart attack or poorly controlled irregular heartbeat in the 6 months before joining, or who have an abnormal heart rhythm measurement (QTc interval) above a certain level on an ECG.
• People with significant heart failure classified at a severe level (Grade III or IV by standard heart failure guidelines), or whose heart pumping function (left ventricular ejection fraction) is below 50% on an ultrasound of the heart.
• People whose high blood pressure is not well controlled (blood pressure at or above 150/100 mmHg), or who have a history of a severe high blood pressure crisis or related brain complications.
• People who have had major surgery within 28 days before joining the trial (though minor procedures such as tumor biopsy, lymph node biopsy, or a stoma formed due to bowel obstruction are generally acceptable — confirm with trial site).
• People who have previously been treated with immunotherapy drugs that target checkpoints such as PD-1, PD-L1, or CTLA-4.
• People who are currently in another clinical trial, or who finished a previous clinical trial less than 14 days before starting this one.
• People who have cancer-related pain that cannot be adequately controlled.
• People with a known history of serious allergic reactions to any monoclonal antibody medication.
• People with a known allergy or intolerance to the trial drugs oxaliplatin or capecitabine, or any of their ingredients.
• People who are pregnant or currently breastfeeding.
• People who the trial doctors determine have other factors that could make it unsafe or unsuitable for them to continue in the study.

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