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:

• You are 18 years of age or older
• You have been diagnosed with colorectal cancer (a type of bowel cancer) that has spread to other parts of the body
• Your cancer has been confirmed through a tissue sample (biopsy) to be a specific type called adenocarcinoma
• A blood test (liquid biopsy) shows your cancer does not have certain gene changes called RAS or BRAF mutations
• You previously received a treatment containing cetuximab or irinotecan as your first treatment, and your cancer responded well (shrank or disappeared)
• It has been more than 2 months since your last dose of cetuximab from that first treatment
• Your cancer can be measured on scans according to standard guidelines
• You are generally well enough to carry out light activity or desk work (your doctor will assess this using a standard 0–1 scale)
• Your expected survival is more than 12 weeks
• Your blood counts (white blood cells, platelets, and haemoglobin levels) are within an acceptable range
• Your liver function tests are within an acceptable range
• Your kidneys are working well enough (confirm with trial site)
• You agree to use effective contraception during the study and for at least 2 months after the last treatment, if there is any chance of pregnancy

Who may not be able to join:

• You have a known reason why you cannot take cetuximab or the other study drug, envafolimab
• You have or have had another type of cancer, unless it was a fully treated skin cancer or a very early-stage cervical condition
• You are pregnant or breastfeeding
• You have taken part in another clinical trial or received an experimental treatment within the last 30 days
• You are currently taking immune-suppressing medicines (such as steroids), unless you are on a very low dose for a specific medical reason (confirm with trial site for details)
• You have active or worsening neurological symptoms caused by cancer that has spread to the brain
• You have previously had an organ transplant or a stem cell transplant from a donor
• You have a significant ongoing infection, including HIV or AIDS
• You have an active autoimmune disease (a condition where your immune system attacks your own body) that may get worse with immune-stimulating treatment (confirm with trial site, as some conditions may still be eligible)
• You have an active infection that requires treatment through a drip or tablets
• You have had a severe allergic reaction to any of the study drugs or similar medicines, or you have uncontrolled asthma
• You have had a severe allergic reaction to a substance called Polysorbate 80 that caused you to stop treatment
• You still have significant side effects from a previous cancer treatment
• You have a known problem with alcohol or drug misuse
• You have had a stroke or heart attack in the last 6 months, or you have unstable angina, significant heart failure, or a serious uncontrolled heart rhythm problem
• You have a history of serious eye problems, such as keratitis or severe dry eyes (contact lens use is also not recommended during this trial)
• You have other serious medical or psychiatric conditions, including active or recent thoughts of self-harm, that the trial doctor believes make it unsafe for you to participate
• You do not have the legal capacity to give your own consent to take part

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