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 an informed consent form before any study procedures begin
• People aged 18 to 75 years old, of any gender
• People whose general health and ability to carry out daily activities is rated at a good level (ECOG score of 0 or 1), with a life expectancy of more than 3 months
• People who have been confirmed by tissue or cell testing to have colorectal cancer (cancer of the colon or rectum) that has spread or come back
• People whose first treatment course included specific chemotherapy drugs (5-fluorouracil or capecitabine, plus oxaliplatin) combined with a targeted therapy (bevacizumab or cetuximab)
• People whose cancer came back or spread within 12 months of finishing a course of chemotherapy containing oxaliplatin and fluoropyrimidine-based drugs — this is also counted as first-line treatment having stopped working
• People who have at least one area of cancer spread that can be measured on scans, according to standard measurement guidelines
• People whose blood counts, kidney function, and liver function are within acceptable ranges, as tested within 7 days before starting treatment (confirm specific values with the trial site)
• People whose urine protein levels are below a certain threshold (confirm with trial site)
• People whose blood clotting levels are within an acceptable range, including those on blood-thinning medication (confirm with trial site)
• People who are able to use effective contraception during the study and for 90 days after the last dose of study medication — this applies unless the person has gone through menopause naturally or medically, or has had a sterilisation procedure

Who may not be able to join:

• People whose first-line treatment included the chemotherapy drug irinotecan
• People whose tumour has been found to have no mutations in KRAS, NRAS, or BRAF genes, and who did not receive cetuximab as part of their first-line treatment
• People whose cancer has a specific genetic feature known as dMMR or MSI-H (a type of genetic instability in the tumour)
• People with brain or membrane-lining (meningeal) cancer spread that is causing symptoms — unless the brain metastases were treated with radiotherapy or surgery more than 6 months ago and have been stable since
• People who have had serious bleeding episodes, coughed up significant amounts of blood, a stroke, a heart attack, unstable chest pain, poorly controlled heart rhythm problems, or severe heart failure within certain timeframes before starting the study (confirm specific timeframes and thresholds with trial site)
• People with uncontrolled high blood pressure (systolic above 140 mmHg or diastolic above 90 mmHg)
• People with digestive tract conditions that may affect how the study drug is absorbed, such as active stomach ulcers, ulcerative colitis, active bleeding in the gut, or conditions that may cause bowel bleeding, perforation, or blockage
• People who have been diagnosed with another cancer within the past 5 years, except for certain treated skin cancers or cervical cancer in its earliest stage that has been fully removed
• People with known active infections, including HIV, active hepatitis B with detectable virus levels, active hepatitis C with detectable virus levels, or liver cirrhosis
• People who still have side effects from previous cancer treatment that have not resolved (above a mild level), not including hair loss
• People with other medical conditions, abnormal test results, or other factors that the trial team determines would make participation unsuitable or affect the study results (confirm with trial site)

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