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 75 years old at the time of signing the consent form, of any gender
• People who have been diagnosed with a specific type of colorectal or rectal cancer (called MSS/pMMR) confirmed by tissue testing, whose cancer has gotten worse after receiving a standard first-line chemotherapy treatment containing a drug called fluoropyrimidine (note: people who received a specific three-drug chemotherapy combination called FOLFOXIRI as their first treatment are not eligible; certain rules apply about when treatment is considered to have failed — confirm with trial site)
• People whose general physical fitness is rated at 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People whose doctors estimate they are likely to live at least 12 weeks
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines
• People whose liver, kidneys, and other organs are functioning well enough (confirm with trial site for specific values)
• People of childbearing potential who agree not to try to become pregnant during the study and for 6 months after the last dose, and who agree to use highly effective contraception along with their partner; women of childbearing potential must have a negative pregnancy blood test within 7 days before starting the trial and must not be breastfeeding
• People who are able to read, understand, and sign a consent form agreeing to follow the study requirements

Who may not be able to join:

• People who have cancer that has spread to the membranes around the brain or spinal cord, or who have active brain metastases that are untreated, causing symptoms, or requiring certain medications to control symptoms (people who have already had brain metastases treated with surgery or radiation and have been stable and symptom-free for at least 4 weeks, and off certain medications for at least 2 weeks, may still be considered — confirm with trial site)
• People who have fluid build-up around the lungs, abdomen, or heart that is causing symptoms or needs repeated procedures such as draining
• People with a history of immune system disorders, a positive HIV test, or who have had an organ transplant or stem cell transplant from another person
• People with a history of serious heart or blood vessel problems, including a heart attack in the last 6 months, severe chest pain, certain types of heart failure or abnormal heart rhythms, aortic aneurysm requiring surgery, blood clots in arteries, serious blood clots in veins, mini-strokes, or stroke
• People who have had a hole in the gut, an abdominal abscess, or a fistula (an abnormal connection between body parts) in the abdomen or throat/food pipe area within the past 6 months
• People who have had a serious infection in the past 28 days (such as severe pneumonia or a blood infection), are currently receiving intravenous antibiotics or other infection treatments, or have had an unexplained high fever (above 38.5°C) in the past 2 weeks (unless the fever is judged by the doctor to be caused by the cancer itself)
• People with active tuberculosis, active hepatitis B (with detectable virus levels), or active hepatitis C (with detectable virus levels)
• People who have had another cancer in the past, unless it was fully treated more than 5 years ago with no known signs of return, and is considered low-risk for coming back (such as certain treated skin cancers)
• People whose scans show the tumour is wrapped around major blood vessels or has significant breakdown that could cause bleeding risk; people who have had signs of bowel blockage in the past 6 months; people with serious unhealed wounds, active ulcers, or untreated broken bones; people who have had significant coughing up of blood or tumour-related bleeding in the past month; people with poorly controlled high blood pressure or a history of hypertensive emergency; or people the trial doctor considers unsuitable for a drug called bevacizumab
• People who still have significant side effects from previous cancer treatments that have not returned to an acceptable level (confirm with trial site for specific grade definitions)
• People who previously had to permanently stop taking bevacizumab or a similar drug due to a serious drug-related side effect
• People who received chemotherapy, immunotherapy, radiation, or other anti-cancer treatments (including certain oral or herbal treatments) within 14 days before starting the trial; people who had major surgery within 28 days, or a needle biopsy or minor procedure within 7 days before starting
• People who have taken high-dose steroid tablets or other immune-suppressing medications in the 2 weeks before starting (inhaled or topical steroids are generally acceptable — confirm with trial site)
• People who received a live or weakened-virus vaccine within 28 days before starting, or who would need one during the study
• People who have taken blood-thinning or anti-clotting medications for treatment purposes within 10 days before starting
• Women who are pregnant or breastfeeding
• People with other serious physical or mental health conditions, or significant abnormal test results, that the trial doctor believes would make participation unsafe or affect the reliability of the study results

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