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 been diagnosed with colorectal cancer (a type of bowel cancer) confirmed by a laboratory tissue test, specifically a type called adenocarcinoma
• People whose tumour was originally tested and found to have no RAS or BRAF gene mutations (called "wild-type")
• People who received a first course of chemotherapy (FOLFOX, FOLFIRI, or FOLFOXIRI) combined with the drug cetuximab, and whose cancer responded or stayed stable for at least 6 months
• People whose cancer started growing again either during that first treatment or within 3 months of finishing it
• People whose cancer has continued to grow after receiving at least one further round of treatment after that first course
• People for whom at least 4 months have passed since their last dose of cetuximab
• People who have at least one tumour that can be measured on a scan, according to standard measurement rules (RECIST v1.1)
• People whose blood test (ctDNA test) confirms the cancer still has no RAS or BRAF gene mutations at the time of joining
• People whose blood counts are within acceptable ranges — including platelets, white blood cells, neutrophils, and haemoglobin (confirm specific values with trial site)
• People whose liver blood test results are within acceptable ranges for bilirubin and liver enzymes (confirm specific values with trial site)
• People with no fluid build-up in the abdomen, normal blood clotting, and a blood protein (albumin) level at or above a certain threshold
• People with good liver function, rated as Child-Pugh class A (a standard medical scoring system for liver health)
• People whose kidney function is within an acceptable range, based on a blood test or a calculated measure of how well the kidneys filter waste
• People who are reasonably active and able to care for themselves, rated 0 or 1 on a standard activity scale used by doctors (ECOG scale)
• People whose doctors estimate they are likely to live for more than 3 months
• People who are willing and able to sign a consent form agreeing to take part
• People who are willing to attend follow-up appointments for the duration of the study

Who may not be able to join:

• People whose cancer has RAS or BRAF gene mutations
• People who have severe blockages in their arteries or fluid build-up in the abdomen (ascites)
• People who have a tendency to bleed easily or have problems with blood clotting
• People who have had a severe spike in blood pressure (hypertensive crisis) or related brain complications
• People with serious, uncontrolled health conditions such as active infections or poorly controlled diabetes
• People with significant heart or blood vessel problems, including a stroke or heart attack in the past 6 months, uncontrolled high blood pressure, unstable chest pain, heart failure, or a heart rhythm problem requiring medication
• People who have a history of, or signs of, central nervous system conditions such as a primary brain tumour, epilepsy not controlled by standard treatment, cancer that has spread to the brain, or a previous stroke
• People who have had another type of cancer in the past 5 years (with some exceptions, including certain treated skin cancers, cervical carcinoma in situ, and thyroid cancer — confirm with trial site)
• People who have a known allergy to any of the medications used in this trial
• People who are pregnant or breastfeeding
• People of childbearing potential (within 2 years of their last period) or men who could father a child, who are not willing to use effective non-hormonal contraception during the trial
• People who are unable or unwilling to follow the trial's procedures and schedule
• People with any other serious illness, significant physical impairment from their cancer, or other concerning findings that a doctor determines would make participation unsafe

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