Phase 2 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:

• Adults aged 18 or older who have given their signed consent to take part
• People who have been diagnosed with colorectal cancer (cancer of the colon or rectum) confirmed by tissue testing, which has spread to other parts of the body (metastatic), with at least one area of cancer that can be measured on a CT or MRI scan taken within 5 weeks before joining the trial
• People whose spread of cancer cannot be removed by surgery, or who are unable or unwilling to have surgery
• People whose cancer has a specific genetic profile called "RAS wild-type" (meaning certain genetic mutations in the KRAS and NRAS genes are not present), confirmed by an approved test on tumor tissue
• People who are not suitable for, or who are unwilling to receive, combination chemotherapy, as determined by their doctor
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning they are able to carry out some or all daily activities, with or without some limitations)
• People whose blood tests show that their bone marrow, liver, and kidneys are functioning at an acceptable level, including adequate blood cell counts, liver enzyme levels, and kidney function (confirm specific values with trial site)
• People who are not on blood-thinning medication and have normal blood clotting levels, OR people who are on a stable dose of blood-thinning medication for at least 2 weeks before joining, with acceptable clotting test results
• Women who could become pregnant must have a negative pregnancy test within 14 days before joining, and must agree to use highly effective contraception (less than 1% failure rate per year) or remain abstinent during the treatment period and for at least 6 months after the last dose
• Men must agree to use a condom plus an additional highly effective contraceptive method, or remain abstinent, and must not donate sperm during treatment and for 6 months after the last dose

Who may not be able to join:

• People who have already received treatment specifically for their metastatic cancer (note: prior chemotherapy given after surgery is allowed if it was completed more than 3 months before joining)
• People with known cancer that has spread to the brain, or who have symptoms suggesting this
• People with serious heart conditions, such as severe heart failure, a heart attack within the past 6 months, a balloon heart procedure within the past 6 months, uncontrolled irregular heartbeat, or unstable chest pain
• People who have had a mini-stroke or stroke within the past 6 months, or who have a history of a brain or major artery aneurysm or tear
• People who have had a blood clot in a vein or lungs within the past 6 months, or more than one blood clot event in the past 2 years
• People who have had a serious bleeding event in the past 6 months (except bleeding from a tumor that was treated by surgical removal)
• People with a known tendency to bleed or significant problems with blood clotting
• People with high blood pressure that is not controlled by medication (systolic at or above 160 mmHg and/or diastolic at or above 100 mmHg)
• People with severe wounds, sores, or ulcers that are not healing, or untreated broken bones
• People with a history of a fistula (abnormal connection) in the abdomen or food pipe, a hole in the gut, or an abdominal abscess unrelated to surgery, within the past 6 months
• People with a current bowel blockage, active inflammatory bowel disease, or ongoing chronic diarrhoea
• People with a history of certain eye conditions, including keratitis (inflammation of the cornea), ulcerative keratitis, or severe dry eye
• People with a known allergy or sensitivity to any of the study drugs (trifluridine/tipiracil, panitumumab, or bevacizumab) or their ingredients, or to products made from Chinese hamster ovary cells, or to human or humanised antibodies
• People currently taking, or who have taken within the past 10 days, certain blood-thinning or anti-platelet medications above specified doses, including aspirin over 325 mg/day, dipyridamole, ticlopidine, clopidogrel over 75 mg/day, or cilostazol
• People who have had a major surgery, open biopsy, or significant injury within the past 28 days, or who are expected to need major surgery during the trial, or who have not yet recovered from a previous surgery
• People who have had a core biopsy or minor surgical procedure within 3 days before the first dose of one of the study drugs (bevacizumab), excluding placement of a vascular access device
• People with a history of certain lung conditions, including pulmonary fibrosis, certain types of lung inflammation, or drug-related lung damage, or who show signs of active lung inflammation on a chest scan
• People with any other serious illness, condition, or abnormal test result that their doctor believes would make participation unsafe or affect the trial results
• People with a history of another cancer, unless they have been cancer-free for at least 3 years, or had a fully treated and removed early-stage skin, cervical, breast, prostate, or uterine cancer, or have a cancer type associated with a 5-year survival rate of 90% or more that does not need active treatment
• People with known alcohol or drug misuse problems
• Women who are pregnant or breastfeeding
• People who have taken part in another clinical trial or received an experimental treatment within 28 days before joining (or within 5 half-lives of the experimental drug, whichever is longer), or who would be in another trial at the same time
• People who are in institutional care by legal or administrative order
• People who may be dependent on, or closely related to, one of the trial investigators
• People who do not have full legal capacity to consent

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