Phase 3 Colorectal Cancer Trial, Recruiting

Written by an AI model from the 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 (specifically adenocarcinoma) that cannot be removed by surgery, not including cancer of the appendix or anal canal
• People aged 18 or older at the time of giving consent to participate
• People whose general physical condition is rated as reasonably functional (a medical rating scale from 0–2 will be used to assess this — confirm with trial site)
• People who are willing and able to provide written consent before any trial-related assessments begin
• People who are expected to live for at least 90 days
• People who stopped their first round of chemotherapy for metastatic colorectal cancer because of severe side effects or because the cancer continued to grow, or whose cancer came back within 180 days of finishing an earlier course of chemotherapy after surgery
• People whose blood, liver, and kidney test results fall within acceptable ranges, based on tests done within 14 days before joining (and who have not had a blood transfusion or certain blood-stimulating treatments in the 14 days before those tests)

Who may not be able to join:

• People who have had another type of cancer within the past 5 years, with some exceptions such as certain skin cancers, cervical cancer in situ, or some early digestive tract cancers treated successfully by a specific endoscopic procedure
• People who have a large build-up of fluid around the lungs or in the abdomen that requires medical treatment to drain
• People with a brain tumour or cancer that has spread to the brain, as shown on imaging scans
• People with an active infection, including hepatitis
• People with any of the following conditions: bleeding or blockage in the digestive tract, symptomatic heart disease (such as unstable chest pain, heart attack, or heart failure), lung scarring or inflammation, uncontrolled diabetes, or severe diarrhoea that interferes with daily life despite treatment
• People with a history of a heart attack within the past year, or two or more heart attacks at any point in their life
• People who have had a serious allergic reaction to any of the study drugs, or who have shown signs of being unable to process a drug called fluoropyrimidine properly (a condition called DPD deficiency)
• People who have previously been treated with a drug called irinotecan hydrochloride
• People currently being treated with a drug called atazanavir sulfate
• People who have taken a specific combination of drugs (tegafur, gimeracil, and oteracil potassium) within 7 days before joining
• People who are pregnant or breastfeeding, or people who are unwilling to use contraception during the trial
• People who require ongoing treatment with steroid medicines taken throughout the body (not just applied to the skin)
• People with a mental health condition that would make it difficult to follow the trial requirements
• People considered unsuitable for the trial by the trial doctor, for any other reason
• People who currently have a hole (perforation) in their digestive tract, or who have had one within the past year
• People who have had significant bleeding from the lungs within the past month
• People who have had major abdominal or chest surgery, or bowel removal surgery, within the past 28 days
• People with wounds, stomach or intestinal ulcers, or bone fractures that have not healed (except for a small wound from a medical port implant)
• People who currently have or have had a blood clot or stroke within the past year
• People who are currently taking, or who need, blood-thinning medication above a certain dose (more than 325 mg per day of aspirin)
• People with a known tendency to bleed or a blood clotting disorder, or whose blood clotting test result is above a certain level within 14 days before joining
• People with high blood pressure that is not under control
• People whose urine test shows a higher-than-acceptable level of protein

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