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 between 18 and 75 years old.
• People whose general health and ability to carry out daily activities falls within an acceptable range, based on a standard medical scoring system (called ECOG performance status 0–1).
• People who have been confirmed through laboratory tissue testing to have rectal adenocarcinoma (a specific type of rectal cancer).
• People whose tumour is located in the lower part of the rectum, either below a certain internal boundary or within 10 cm of the opening of the bowel.
• People whose cancer is at a specific stage — meaning the tumour has grown into or beyond the bowel wall, or has spread to nearby lymph nodes, but has not spread to distant parts of the body (confirm with trial site for full staging details).
• People whose bone marrow is functioning well enough, shown by blood test results meeting minimum levels for white blood cells, platelets, and haemoglobin.
• People whose liver is functioning well enough, based on blood test results for liver-related markers falling within acceptable ranges.
• People whose kidneys are functioning well enough, based on blood test results meeting minimum levels for kidney function.
• People who are willing to undergo a specific gene test (called UGT1A1) and whose result comes back as a particular gene type (11 or 128).
• People who agree to follow the treatment plan used in this study and have signed a consent form.

Who may not be able to join:

• People who have had another type of cancer within the past 5 years, unless it was a fully treated, non-invasive skin cancer or similar low-risk cancer.
• People who currently have an active bacterial, viral, or fungal infection that requires ongoing treatment.
• People who have an active HIV infection.
• People who have other serious ongoing health conditions that are not under control.
• People who have a known allergy or sensitivity to any of the drugs used in this study or their ingredients.
• People whose health makes radiation therapy, chemotherapy, or surgery medically unsuitable.
• People who are currently taking certain strong medications that affect how specific liver enzymes process drugs (CYP3A, CYP2C8, and UGT1A1 pathways) — confirm specific medications with the trial site.
• People who are pregnant, breastfeeding, or of childbearing age who are not willing to use contraception during the trial.
• People who have difficulty understanding questions, completing questionnaires, or who have a diagnosed mental health condition that would make participation difficult.
• People who do not meet the inclusion criteria listed above, or who the trial investigators determine are not suitable to participate for other medical reasons.

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