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 signed a written consent form before any study procedures begin
• People aged 18 to 75 years old
• People who have been diagnosed with advanced (Stage IV) colorectal cancer, confirmed through a tissue or cell sample
• People whose cancer has a specific genetic profile called MSS (microsatellite stable) — (confirm with trial site)
• People who have already tried at least two standard chemotherapy treatments (based on specific drugs including fluorouracil, oxaliplatin, irinotecan, bevacizumab, and cetuximab) and whose cancer either stopped responding or caused intolerable side effects
• People with a good general physical condition, rated 0 or 1 on a standard medical scale called ECOG — meaning fully active or able to carry out light activities (confirm with trial site)
• People who have at least one measurable tumour that can be tracked during the study
• People whose doctors expect them to live for at least 12 weeks
• People whose liver and kidney function blood test results fall within acceptable ranges as defined by the trial (confirm with trial site)
• People whose blood clotting test results fall within acceptable ranges as defined by the trial (confirm with trial site)
• People who have had radiotherapy in the past may be considered, provided it was completed more than 4 weeks before joining, and the tumour being studied was not previously treated with radiotherapy
• People who are capable of having children and who agree to use effective contraception throughout the study and for 6 months after the last dose of study medication

Who may not be able to join:

• People who have previously received certain immunotherapy drugs, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments, or similar experimental immune drugs
• People with serious autoimmune diseases, such as active inflammatory bowel disease (including Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, lupus, or autoimmune blood vessel diseases
• People with symptomatic lung inflammation (interstitial lung disease) or active lung infection or non-infectious pneumonia
• People with conditions that raise the risk of a bowel perforation (a hole in the intestine), such as active diverticulitis, abdominal abscess, bowel blockage, or other known risk factors
• People who have had recent surgery and whose wound has not fully healed
• People with a history of other cancers, except for certain cured localised cancers such as skin basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or certain early-stage cancers of the prostate, cervix, or breast
• People who are planning to have, or have previously had, an organ transplant or bone marrow transplant
• People with moderate or severe fluid build-up in the abdomen (ascites) requiring drainage, a liver function score above a certain level, or uncontrolled fluid around the lungs or heart
• People who have had gastrointestinal bleeding or a clear risk of it in the 6 months before starting treatment
• People who have developed a fistula, bowel perforation, or abdominal abscess in the 6 months before starting the study
• People with known bleeding or clotting disorders, or who have recently used full-dose blood thinning or clot-dissolving medications (within 10 days before starting the study) — low-dose aspirin or preventive low-molecular-weight heparin may be allowed
• People currently using or who have recently used (within 10 days) high-dose aspirin (over 325 mg per day) or certain other blood-thinning medications such as clopidogrel, dipyridamole, ticlopidine, or cilostazol
• People who have had a stroke, mini-stroke, brain bleed, or pulmonary embolism (blood clot in the lungs) within the 6 months before starting the study
• People who have had an active infection, heart failure, heart attack, unstable angina, or unstable heart rhythm within the last 6 months
• People whose doctors believe they have findings that could interfere with the study or put them at increased risk of complications, or who have other uncontrolled medical conditions
• People whose doctors believe they urgently need radiotherapy or emergency surgery (for example, for spinal cord compression, brain swelling, or broken bones)
• People who are pregnant or breastfeeding
• People with a history of immune system deficiency, including HIV, other inherited or acquired immune conditions, or a history of organ transplantation
• People with mental illness, substance use issues, or social circumstances that doctors believe would affect their ability to follow the study requirements
• People with known active infections or active tuberculosis — however, people with stable hepatitis B or hepatitis C that is being managed with antiviral treatment may be considered
• People who have received a live vaccine within 30 days before joining the study
• People with heart conditions that are not well controlled
• People with high blood pressure above specific levels (systolic above 140 mmHg or diastolic above 90 mmHg) regardless of blood pressure medication, or a history of hypertensive crisis or hypertensive encephalopathy
• People who have had major blood vessel disease, such as an aortic aneurysm requiring surgery or recent blood clot in a peripheral artery, within the past 6 months
• People with severe unhealed or open wounds, active ulcers, or untreated broken bones
• People who have had major surgery within 4 weeks before starting the study, or who are expected to need major surgery during the study
• People who are unable to swallow tablets, or who have conditions affecting how food and medication are absorbed in the gut
• People who have had a bowel obstruction or signs and symptoms of one within the 6 months before starting the study, unless it was fully resolved through surgery
• People with unexplained gas build-up in the abdomen
• People whose cancer has spread to involve a major airway or blood vessel, or who have a large tumour mass near the centre of the chest (within 30 mm of a specific anatomical landmark — confirm with trial site)
• People with a history of a condition called hepatic encephalopathy (brain problems caused by liver disease)
• People who currently have, or have previously had, interstitial lung disease or pneumonia requiring steroid treatment, or certain other lung conditions that could make it harder to manage potential treatment side effects
• People with active autoimmune diseases, or a history of autoimmune disease that may return — some conditions such as vitiligo, controlled type 1 diabetes managed with insulin, or childhood asthma fully in remission may be considered (confirm with trial site); people with asthma requiring ongoing medication are not included
• People who have used immune-suppressing medications or systemic steroids for immune suppression within 14 days before starting the study
• People with a known history of severe allergic reactions to monoclonal antibody treatments or anti-angiogenesis drugs
• People who have had a severe infection in the 4 weeks before starting the study, or who have received antibiotic treatment (oral or intravenous) within 2 weeks before starting
• People who, in the treating doctor's judgement, have other factors that could affect the study results or their safety, including significant abnormal lab results or difficult family or social circumstances

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