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 are able to understand the study and sign a consent form before any study procedures begin
• People aged 18 to 75 years old, of any gender
• People whose general physical fitness is rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physically demanding activity (confirm with trial site)
• People whose doctors expect them to live for at least 3 months
• People who have been confirmed by laboratory tissue testing to have colorectal cancer (a type called adenocarcinoma) that has come back or spread and cannot be cured
• People whose genetic testing shows a mutation in the RAS gene (including KRAS or NRAS), or whose cancer started in the right side of the colon (including the cecum, ascending colon, or the right two-thirds of the transverse colon)
• People who have not yet received any systemic (whole-body) treatment for their recurrent or metastatic colorectal cancer
• People who have at least one tumour that can be measured on scans, according to standard criteria (RECIST v1.1), and who agree to provide a tumour tissue sample (either stored or freshly collected)
• People whose previous cancer treatment (adjuvant therapy) finished more than 12 months before joining this trial
• People whose blood, kidney, liver, clotting, and thyroid function results meet the specific healthy levels required by the trial (confirm with trial site for exact values)
• Women who are able to become pregnant must have a negative blood pregnancy test within 72 hours before the first dose, and must use an effective form of contraception from screening until at least 120 days after the last dose of study medication (periodic or calendar-based methods are not accepted)

Who may not be able to join:

• People who have previously been treated with certain immune checkpoint drugs, specifically PD-1, PD-L1, or CTLA-4 antibody therapies
• People whose tumour tissue shows a specific genetic feature called dMMR or MSI-H
• People who received local palliative treatment, certain immune-modifying therapies, or specific traditional Chinese medicines with anti-tumour indications within 2 weeks before joining the trial
• People who are currently enrolled in another interventional clinical trial
• People who have had, or currently have, another cancer diagnosed within the past 3 years — with some exceptions for certain fully treated early-stage cancers such as cervical carcinoma in situ, non-melanoma skin cancers, and certain superficial bladder tumours
• People with active or untreated brain or spinal cord metastases — though people with treated, stable brain metastases who meet specific conditions may still be considered (confirm with trial site)
• People who have fluid build-up around the lungs, heart, or abdomen that needs to be drained frequently (at least once per month)
• People with active autoimmune diseases that required systemic treatment within the past 2 years, with some exceptions for milder conditions such as certain skin conditions, stable thyroid disease, or stable type 1 diabetes
• People who have had serious heart or blood vessel events within recent months, including heart attack, stroke, severe heart failure, serious blood clots, or uncontrolled high blood pressure — specific timeframes apply to each condition (confirm with trial site)
• People with a history of myocarditis or cardiomyopathy, or whose heart pumping function (LVEF) is below 50%
• People still experiencing significant side effects from previous cancer treatment that have not resolved to a mild level
• People with known lung inflammation (interstitial lung disease or non-infectious pneumonia) that is currently causing symptoms or required steroid treatment in the past
• People with known active tuberculosis
• People who received systemic antibiotics or other anti-infective treatments (other than hepatitis B or C antiviral therapy) within the 2 weeks before joining
• People who have had an organ transplant or bone marrow/stem cell transplant from another person
• People whose scans show the tumour is growing into or closely intertwined with major blood vessels
• People with active diverticulitis, abdominal abscess, bowel blockage, or wounds, ulcers, or fractures that have not healed
• People who have had significant bleeding, a bleeding disorder, or are taking blood-thinning or antiplatelet medications above certain low maintenance doses, within the past month
• People who had major surgery or a significant injury within 28 days before joining the trial
• People with a known immune deficiency condition, a positive HIV test, or an active syphilis infection
• People who required higher-dose steroid medications or other immune-suppressing drugs in the 14 days before joining — with certain low-dose or localised exceptions allowed
• People with active hepatitis B where the virus level is above a certain threshold and is untreated, or active hepatitis C infection — people with hepatitis B may be considered if they are receiving appropriate antiviral treatment during the study
• People who received a live vaccine within 30 days before joining, or who plan to receive one during the study
• People with a known allergy or serious reaction to any of the study drugs used in this trial, including cadonilimab, bevacizumab, capecitabine, or oxaliplatin, or who have had a severe allergic reaction to other monoclonal antibody treatments
• People whose doctors determine that other health conditions or circumstances make participation unsafe or unsuitable

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