Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from the 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 to 75 years old at the time of signing the consent form.
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (ECOG), meaning fully active or able to carry out light work (confirm with trial site).
• People whose colon or rectal cancer has been confirmed by tissue testing to be a specific type called MSS or pMMR adenocarcinoma.
• People whose cancer has spread (metastasised) to no more than 10 spots in the body, and where all affected areas can be safely treated with radiation based on pre-treatment planning.
• People who have at least one measurable area of cancer spread that can be treated with radiotherapy and tracked using standard imaging measurements.
• People who have not had radiotherapy in the past 6 months.
• People who fall into one of two groups: those who have not yet received first-line (initial) chemotherapy (Cohort A), or those whose cancer progressed after first-line chemotherapy or who had to stop it due to serious side effects (Cohort B).
• People whose doctor estimates they have a life expectancy of at least 24 weeks.
• People whose bone marrow, liver, kidney, and blood clotting function are all within acceptable levels, based on blood tests done within 7 days before starting the trial, without needing blood transfusions or growth factor support.
• People who are not pregnant or breastfeeding, and who agree to use effective contraception during the trial and for 6 months after the last dose.
• People who have been fully informed about the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who have previously been treated with checkpoint inhibitor therapy (a type of immunotherapy).
• People whose blood test results show low levels of certain blood cells (white blood cells, platelets, or haemoglobin) below specified thresholds.
• People whose liver function blood tests are above certain limits, with higher thresholds applying if cancer has spread to the liver.
• People whose kidney function test results are above certain limits, or whose kidneys are not filtering blood efficiently enough.
• People whose blood clotting test results are above certain limits.
• People with serious imbalances in their body's electrolyte (salt and mineral) levels.
• People with too much protein in their urine, based on a urine test.
• People with uncontrolled high blood pressure (above 140/90 mmHg).
• People who have had a blood clot in an artery or deep vein in the past 6 months, or a history of bleeding or signs of a bleeding tendency in the past 2 months.
• People with a history of heart disease within the past 6 months.
• People with uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart.
• People who have another active cancer, or who have had a different cancer within the past 5 years.
• People with a history of certain liver conditions, including hepatitis B or C infection, positive test results for these viruses above specified levels, or liver cirrhosis.
• People who are pregnant, breastfeeding, or who test positive for pregnancy before starting the trial, or people (and their partners) who are unwilling to use strict contraception throughout the study.
• People who, in the opinion of the investigating doctor, are not suitable for the trial due to any medical, laboratory, or compliance-related concerns.
• People with serious mental health conditions.
• People who have brain metastases (cancer that has spread to the brain) where any single affected area is larger than 3 cm in diameter, or where the total volume of affected areas exceeds 30 cc.
• People who have clinical or scan-based signs of pressure on the spinal cord, or tumours located within 3 mm of the spinal cord on MRI.

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