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 aged 18 or older who are willing and able to follow the study procedures and give written consent to participate.
• People who are in good general health and able to carry out normal daily activities with little to no limitation (as measured by a standard performance scale).
• People with a life expectancy of at least 5 years, not counting any cancer diagnosis.
• People who have been confirmed by laboratory testing to have rectal adenocarcinoma (a specific type of rectal cancer) with particular tumour characteristics confirmed by a central laboratory, including a specific DNA repair pattern (called MSS) and certain gene-related markers (MGMT expression and methylation).
• People whose cancer is locally advanced but still considered surgically removable, meeting specific criteria about tumour location, size, lymph node involvement, and absence of spread — as assessed by MRI, CT scan, and PET/CT scan.
• People whose tumour can be removed with the goal of a cure (which may include extensive pelvic surgery if needed).
• People whose blood counts and organ function (including blood cells, liver, and kidneys) fall within acceptable ranges on testing.
• People for whom a stored tumour tissue sample is available for central laboratory testing, or who can provide a minimum number of tissue sections if a full sample block is not available.
• Male participants with female partners who could become pregnant must be willing to use adequate contraception from the first dose of treatment until 180 days after the last dose (confirm with trial site for approved methods; abstinence is accepted if it is the person's usual practice).
• Female participants who could become pregnant must have a negative blood pregnancy test at the start of the study and must be willing to use effective contraception throughout the study and for 180 days after the last treatment dose (confirm with trial site for approved methods; abstinence is accepted if it is the person's usual practice).

Who may not be able to join:

• People with a genetic enzyme deficiency called DPD deficiency, which affects how certain chemotherapy drugs are processed by the body.
• People who have previously had radiation therapy to the pelvis.
• People who have had a heart attack, severe chest pain, heart bypass surgery, significant heart failure, stroke, mini-stroke, serious heart rhythm problems requiring medication, or a blood clot in the lungs within the 6 months before treatment would start.
• People with uncontrolled blood clotting disorders.
• People with an active infection that requires treatment with systemic (whole-body) medications.
• People with HIV infection who have a very low immune cell count (CD4 below 200/mm³) or who have AIDS-related conditions, even if receiving HIV treatment.
• People who have had a severe allergic reaction to any of the study drugs or their ingredients.
• People with problems affecting the upper digestive tract that prevent normal absorption of medications, or who have immune-related bowel inflammation or active inflammatory bowel disease that requires ongoing treatment or is causing symptoms.
• People whose rectal cancer has spread to other parts of the body, whose cancer has come back, or who have any prior history of invasive rectal cancer regardless of how long ago it was treated.
• People with other types of rectal cancer (such as sarcoma, lymphoma, or others listed in the criteria), or who also have colon cancer at the same time.
• People with a history of other cancers are generally not eligible, unless they have been cancer-free for 3 or more years and their doctor considers them at low risk of it returning. However, people with certain treated skin cancers, early-stage cervical cancer, or early-stage colon or rectal cancer in situ may still be eligible even if diagnosed less than 3 years ago (confirm with trial site).
• People with other serious ongoing medical or psychiatric conditions — including lung inflammation, pulmonary fibrosis, or active or recent suicidal thoughts or behaviour (within the past year) — or abnormal test results that the trial doctor believes would make participation unsafe or affect study results.
• People taking other medications that are known to interact unsafely with the trial drugs.
• People who are pregnant or breastfeeding.

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