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 have voluntarily signed and dated a consent form before any study-related procedures begin.
• People aged between 18 and 75 years.
• People who have been diagnosed with a specific type of rectal cancer (called pMMR/MSS rectal adenocarcinoma) confirmed through laboratory testing of tissue or cell samples.
• People whose rectal tumor is located in the lower part of the rectum, below a certain anatomical boundary in the pelvis.
• People whose cancer is locally advanced with at least one high-risk feature, such as the tumor growing into nearby structures, spread to multiple nearby lymph nodes, cancer cells found in nearby blood or lymph vessels, tumor close to the edge of surrounding tissue, or involvement of lymph nodes along the pelvic side wall (confirm with trial site).
• People with no clear signs that the cancer has spread to distant parts of the body before treatment.
• People who have not previously received any cancer treatment, including radiation, chemotherapy, targeted therapy, or immunotherapy.
• People who are in good general health, able to carry out daily activities, with only mild limitations at most (confirm with trial site).
• People whose recent blood test results — taken within 15 days before starting treatment — show that white blood cell count, neutrophil count, haemoglobin, platelet count, liver enzymes, bilirubin, and kidney function are all within the required ranges (confirm with trial site).
• People who have no other current cancer diagnosis, are not pregnant or breastfeeding, and are willing to use effective contraception during the study and for 6 months after the last dose.

Who may not be able to join:

• People with a history of severe allergic reactions to certain medicines, including platinum-based drugs, 5-FU, or a class of anti-nausea medicines called 5-HT3 receptor antagonists.
• People who have taken part in, or are currently taking part in, another clinical trial within the 4 weeks before enrolling.
• People who have previously received certain types of immunotherapy that work by targeting immune checkpoint or T-cell activation pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 treatments).
• People with severe imbalances in the body's electrolyte (salt and mineral) levels.
• People with active stomach or bowel conditions such as ulcers, ulcerative colitis, tumors that are actively bleeding, or bowel perforations that have not fully healed.
• People who have had an arterial blood clot or deep vein blood clot within the past 6 months, signs of bleeding problems or a bleeding episode within the past 2 months, or who are currently on high-dose blood-thinning medication.
• People who are pregnant or breastfeeding, or whose pregnancy test is positive before the first dose, or who are unwilling to use reliable contraception throughout the study.
• People with another active cancer diagnosis, unless it was fully treated with no return for more than 3 years, or is a very early-stage cancer that can be adequately treated (confirm with trial site).
• People with significant heart problems, including serious irregular heart rhythms on an ECG, active coronary artery disease, severe or unstable chest pain, a heart attack or new chest pain within the past 12 months, or moderate-to-severe heart failure.
• People with an active infection causing a fever above 38°C.
• People with poorly controlled high calcium levels, high blood pressure, or diabetes.
• People with serious lung disease such as interstitial lung disease, pulmonary fibrosis, or severe emphysema.
• People with a mental health condition or nervous system disorder that could affect their ability to take part in the study.
• People with serious complications such as bowel obstruction, significant kidney failure, significant liver failure, or cerebrovascular (brain blood vessel) disorders.
• People who still have unresolved side effects rated as moderate or worse from any previous treatment (with the exception of anaemia, hair loss, and skin colour changes).
• People with any unstable medical condition that could affect their safety or ability to follow the study requirements.
• People considered by the treating doctor running the trial to be unsuitable for participation for any reason.

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