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 to 70 years old
• People who have been diagnosed with colorectal adenocarcinoma (a specific type of bowel cancer), confirmed by tissue testing
• People whose general health and ability to carry out daily activities meets a specific functional standard (known as ECOG score 0–1, meaning fully active or able to carry out light work) (confirm with trial site)
• People with colon cancer where scans show the tumour has grown to a certain depth into or beyond the bowel wall, with no sign of spread to distant parts of the body; or people with rectal cancer where the tumour meets specific size and location criteria on MRI scan, is less than 12cm from the anal opening, and has no distant spread
• People whose tumour has been assessed by a specialist team — including at least two bowel surgeons and one radiologist — as being able to be fully removed by surgery
• People who have not previously received any cancer treatment for their colorectal cancer, including chemotherapy, immunotherapy, or targeted therapy
• People whose blood test results from within the 7 days before treatment show that their blood counts and organ function (liver, kidneys, and blood cells) are within the required ranges (confirm with trial site)
• People who are willing and able to follow the study procedures and attend all required visits

Who may not be able to join:

• People whose cancer has caused a bowel blockage, active bleeding, or a hole in the bowel requiring emergency surgery or a stent
• People with active, known, or suspected autoimmune diseases — with some exceptions, such as type 1 diabetes, thyroid conditions managed only with hormone replacement, or autoimmune conditions not expected to return without a trigger (confirm with trial site)
• People with HIV infection or AIDS, untreated active hepatitis B or C, or co-infection with both hepatitis B and C
• People with a known allergy to the trial treatment or any of its ingredients
• People who have had major surgery or serious physical trauma in the 4 weeks before enrolling, unless the surgical wound has fully healed
• People who currently have or have recently had another active cancer — exceptions may apply for cancers that were fully treated more than 5 years ago with no return, or certain non-invasive cancers treatable by standard care
• People who have previously received certain types of immunotherapy, specifically anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments, or other drugs that act on similar immune pathways
• People who have had active coronary artery disease, unstable or newly diagnosed chest pain (angina), or a heart attack in the 6 months before the study; or who have had a stroke, mini-stroke (TIA), blood clot in the lungs, or deep vein thrombosis in the past 6 months
• People with moderate to severe heart failure (classified as NYHA class II or higher) (confirm with trial site)
• People with active inflammatory bowel disease or other bowel conditions causing ongoing diarrhoea
• People who still have side effects from previous treatments that have not fully resolved (with the exception of anaemia, hair loss, or skin pigmentation changes)
• People with a history of lung conditions such as pulmonary fibrosis, interstitial lung disease, pneumoconiosis, drug-related lung inflammation, or severely reduced lung function
• People with active tuberculosis (TB), or who are currently receiving or have received TB treatment within the year before the first dose
• People with a known syphilis infection that requires treatment
• People who have used immune-suppressing medications in the 4 weeks before the first dose — certain low-dose or inhaled steroids used for conditions like asthma or allergies may be exceptions (confirm with trial site)
• People who have received a live vaccine within 4 weeks before the first dose or during the study
• Women who are pregnant or breastfeeding; women of reproductive age who are not willing to use effective non-hormonal contraception; or men who could father a child and are not willing to use contraception

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