Phase 3 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 been diagnosed with colorectal cancer that has spread to other parts of the body, confirmed by a tissue sample (biopsy), and whose cancer has continued to grow after one round of chemotherapy treatment.
• People whose first treatment for their spreading cancer included one of several specific chemotherapy combinations (such as FOLFOX, FOLFIRI, or FOLFIRINOX), given either alone or alongside certain targeted medicines (bevacizumab or anti-EGFR therapy).
• People whose cancer showed resistance to their first chemotherapy — meaning the cancer kept growing during treatment or came back within 3–6 months of finishing it (the exact timeframe depends on the type of treatment received; confirm with trial site).
• People aged 18 years or older.
• People whose general health and ability to carry out daily activities meets a specific medical standard (a score of 0 or 1 on a scale used by doctors to measure how well a person is functioning day-to-day).
• People who have at least one area of cancer that can be measured on a scan (CT or MRI).
• People whose cancer has been tested and found to have specific molecular features: stable microsatellite status (MSS), no BRAF V600E gene change, and a known RAS gene status.
• People with blood counts, liver function, and kidney function within acceptable ranges as measured by blood tests (confirm specific values with trial site).
• People who are able to receive iodine-based contrast dye used during CT scans.
• Women of childbearing age who have a negative pregnancy test within 14 days before starting the study drug, and who agree to use reliable contraception during the study and for 210 days after the last dose; men are also required to use adequate contraception where applicable.
• People who have signed and dated a consent form agreeing to take part in the trial.
• People who are able to follow the study schedule and requirements, in the opinion of the trial doctor.
• People who are registered with a national healthcare system.

Who may not be able to join:

• People who have been diagnosed with another cancer within the past 2 years (with exceptions for certain skin cancers or early-stage cervical or bladder cancers that have been fully treated).
• People currently taking part in another clinical trial, or who have received an experimental treatment within the past 21 days.
• People whose personal, family, social, or geographical circumstances may make it difficult to follow the trial schedule and requirements.
• People who are under legal guardianship or who have had their freedom restricted by a court.
• People who have a surgical procedure planned within the first month of treatment, or any procedure that could affect the timing of the study drug during that period.
• People who have previously been treated with the study drug, regorafenib.
• People who have previously received anti-cancer medicines that target blood vessel growth, other than bevacizumab.
• People who have a complete lack of an enzyme called DPD, which the body uses to process certain chemotherapy drugs.
• People who have had major surgery, an open biopsy, or a significant injury within 28 days before starting the study drug.
• People who are pregnant or breastfeeding.
• People with moderate to severe heart failure, or chest pain that occurs at rest or has newly started within the last 3 months.
• People who have had a heart attack within the 6 months before starting the study drug.
• People who have heart rhythm problems that require specific medications to control (although beta-blockers and digoxin are allowed).
• People with high blood pressure that is not controlled by medication, or who have a history of a hypertensive crisis or a related brain condition.
• People with a build-up of fluid around the lungs or in the abdomen that is causing breathing difficulties.
• People with an active infection that is moderate or severe in nature.
• People with a known history of HIV infection.
• People with active or chronic hepatitis B or C that requires antiviral treatment.
• People who take medication to control seizures (epilepsy).
• People who have received an organ transplant.
• People with a history of abnormal bleeding or a bleeding disorder of any severity.
• People who have had a significant bleeding episode (grade 3 or above) within 4 weeks before starting the study drug.
• People with a wound that is not healing, an active ulcer, or an untreated bone fracture.
• People with a history of an abnormal opening in the digestive tract, a hole in the gut, an abscess in the abdomen, or active bleeding in the digestive system within the past 6 months.
• People who are dehydrated, even mildly.
• People who have a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have an ongoing lung condition involving inflammation or scarring of lung tissue (interstitial lung disease) with active symptoms.
• People with very high levels of protein in their urine (above 3.5 g per 24 hours).
• People who are unable to swallow tablets or capsules.
• People with conditions that affect the body's ability to absorb medicines, or who still have significant side effects from previous treatments (with some exceptions such as hair loss, an underactive thyroid, or mild nerve-related side effects from a specific chemotherapy).
• People currently receiving or who have recently received other cancer treatments, including chemotherapy, immunotherapy, or hormone therapy (within the past 3 weeks).
• People who have taken another experimental medicine within the past 28 days (aspirin is an exception).
• People taking certain other medications that are known to interact with the study drug, regorafenib (confirm specific medicines with trial site).

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