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 (any gender) who are willing and able to sign a consent form and follow the trial's visit schedule and procedures.
• People with a laboratory-confirmed diagnosis of advanced colorectal cancer (cancer that has spread or cannot be removed by surgery).
• People whose colorectal cancer has been tested and confirmed as a specific type that does not respond well to certain immune therapies — described in medical terms as mismatch repair-proficient (pMMR), microsatellite instability-low (MSI-L), or microsatellite stable (MSS) — based on standard local testing (applies to both Cohort 2 and Cohort 9; for Cohort 9, this applies if test results are available).
• For Cohort 9 only: People whose most recent scans show no active cancer spread to the liver at the time of joining the trial.
• For Cohort 9 only: People who previously had liver metastases that were treated with surgery, microwave or radiofrequency ablation, or stereotactic radiotherapy (but not a procedure called transarterial chemoembolization) at least 6 months before joining, and whose follow-up scans confirm no remaining liver metastases.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 6 months after the last dose of the study drug.
• People with active or untreated cancer that has spread to the brain or the lining of the brain or spinal cord — though people with brain metastases that cause no symptoms, or whose brain metastases have been treated and have been stable for at least 2 weeks, may still be considered if certain additional conditions are met (confirm with trial site).
• People who have had a blood clot in a vein (deep vein thrombosis) or in the lungs (pulmonary embolism) within the 4 weeks before starting the trial, unless the clot has been fully treated and the treating doctor considers it stable.
• People with serious heart or blood vessel conditions, including uncontrolled irregular heartbeat, severely high blood pressure despite treatment, heart failure, a heart attack or stroke within the past 6 months, a very low heart pumping function, active seizures, or several other significant heart-related conditions (confirm with trial site for the full list).
• People with certain lung conditions, such as scarring of the lung tissue, drug-related lung inflammation, or severe breathing problems.
• People with a history of allergic conditions such as asthma or a skin condition called atopic dermatitis, or a known tendency toward allergic reactions.
• People who have recurring fluid build-up around the lungs, heart, or abdomen that requires repeated draining.
• People with active autoimmune diseases (where the immune system attacks the body) that have required systemic medical treatment within the past 2 years — with some exceptions for common replacement therapies such as thyroid hormone or insulin (confirm with trial site).
• People who have previously had an organ transplant or a stem cell transplant from another person.
• People with a known or suspected allergy to the study drug or its ingredients.
• People who previously had to permanently stop an immune checkpoint inhibitor (a type of cancer drug) due to serious side effects.
• People who still have unresolved moderate-to-severe side effects from previous cancer treatments — with some exceptions for certain ongoing but stable conditions (confirm with trial site).
• People who have not fully recovered from surgery, or who have had major surgery within 4 weeks before starting the trial.
• People with active, uncontrolled bleeding or a known bleeding disorder.
• People with significant bowel conditions within the past 6 months, such as inflammatory bowel disease, radiation damage to the bowel, or significant diarrhoea within 2 weeks before starting the trial.
• People with uncontrolled pain caused by their cancer, or high calcium levels caused by their cancer.
• People with known HIV infection, active hepatitis B or C, or active tuberculosis — though people with hepatitis B or C who meet specific viral load thresholds or have completed treatment may still be considered (confirm with trial site).
• People who have had a severe infection requiring intravenous antibiotics within 2 weeks before starting the trial, or who have an unexplained fever above 38°C.
• People diagnosed with another cancer within the past 5 years — with exceptions for certain cancers that have been fully cured, such as some skin cancers, localised prostate cancer, or papillary thyroid cancer.
• People who have recently received certain medications or treatments, including specific chemotherapy drugs, immune therapies, live vaccines, immunosuppressants, or other investigational treatments within defined time periods before starting the trial (confirm with trial site for the full list of timeframes).
• People with a specific genetic variation affecting how the body processes a drug called irinotecan (UGT1A1 gene variants *6/*6, *28/*28, or *6/*28).
• People who have had extensive radiotherapy to the abdomen or pelvis in a way that may affect bone marrow or bowel function, as assessed by the treating doctor.
• People with severe psychiatric conditions, significant cognitive impairment, or substance use problems that could affect their ability to give informed consent or follow the trial requirements.
• For Cohort 2 only: People whose colorectal tumour shows signs of bleeding, risk of blockage, or risk of perforation (a tear in the bowel wall).
• For Cohort 2 only: People who previously had to permanently stop bevacizumab, oxaliplatin, capecitabine, or 5-FU due to serious side effects.
• For Cohort 9 only: People who previously had to permanently stop bevacizumab, fruquintinib, or trifluridine/tipiracil due to serious side effects, or who have other reasons the treating doctor considers to be a contraindication to these drugs.
• People with any other condition or circumstance that the trial doctor believes could affect safety or the reliability of trial results.

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