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 aged 18 to 70 years old at the time of signing the consent form
• People whose general physical functioning is rated as good (scored 0 or 1 on a standard oncology scale), with this rating remaining stable in the 2 weeks before joining, and with an expected survival of at least 12 weeks
• People who have been confirmed by tissue or cell testing to have stage II high-risk or stage III low-risk colon cancer (a specific type called adenocarcinoma), that is not the type with high microsatellite instability (MSI-H), classified according to an international cancer staging system (8th edition); high-risk stage II includes factors such as tumour growing into nearby structures, poorly formed cancer cells, blood or nerve vessel involvement, blockage or perforation of the bowel before surgery, uncertain or close surgical margins, or fewer than 12 lymph nodes examined; stage III low-risk means the cancer has spread to a limited number of nearby lymph nodes but not to distant ones or more advanced lymph node involvement
• People with no evidence that the cancer has spread to distant parts of the body, confirmed by thorough medical testing
• People whose tumour is located at least 12 cm from the anal opening, as measured by pre-surgery scope examination, imaging, or assessment during surgery if a scope exam was not done beforehand
• People who have not had pre-surgery treatment for their cancer and whose cancer can be removed completely by surgery (called R0 resection)
• People for whom enough fresh surgical tissue can be collected for specialised genetic testing, and for whom blood samples can be provided before surgery and at specific time points after surgery (days 3–7 and days 21–30 after the operation) for a cancer detection blood test
• Women of childbearing age who test negative for pregnancy before treatment begins, agree to use appropriate contraception from screening until 3 months after treatment ends, and do not breastfeed during that time — or women who meet specific criteria confirming they are post-menopausal or have had a sterilisation procedure (confirm with trial site for details)
• Male participants who agree to use barrier contraception (such as condoms) from screening until 3 months after treatment ends
• People who agree to take part voluntarily and sign a written consent form
• People whose doctors consider them suitable to receive the chemotherapy regimens used in this trial (CAPEOX or mFOLFOXIRI)

Who may not be able to join:

• People who have previously received any pre-surgery treatment, systemic chemotherapy, immunotherapy, or radiotherapy for colon cancer, or who have already had colon cancer surgery
• People who have been diagnosed with another cancer at any time, either in the past or at the same time — except for certain treated skin cancers or early-stage cervical cancer
• People whose colon cancer is a type other than adenocarcinoma (for example, neuroendocrine, sarcoma, lymphoma, or squamous cell types)
• People whose cancer is classified as MSI-H or has deficient mismatch repair (dMMR)
• People with any evidence — from pathology, clinical assessment, or imaging — that the cancer has spread to distant areas of the body
• People with more than one primary colorectal cancer
• People who have had major surgery on another part of the body (not the colon) within 14 days before joining the trial
• People for whom sufficient surgical tissue cannot be collected, or for whom the specialised genetic testing panel cannot be successfully created
• People who cannot provide the required blood samples before surgery and at the required time points after surgery
• People with other serious medical conditions that, in the treating doctor's judgement, may affect their follow-up or short-term survival
• People with medical, social, or psychological conditions that make participation in the study unsuitable
• People who received a blood transfusion within 2 weeks before surgery or during surgery
• People who are unable to undergo contrast-enhanced MRI or CT scans for follow-up monitoring
• People who have previously used Chinese patent medicines with anti-tumour effects — although people who used such medicines for fewer than 7 days and stopped more than 2 weeks ago may still be considered (confirm with trial site)
• People with serious or uncontrolled conditions such as severe mental illness, neurological disease, epilepsy, dementia, unstable heart, lung, liver or kidney disease, reduced heart pumping function, uncontrolled high blood pressure, difficulty swallowing, active gastrointestinal disease significantly affecting how the body processes medication, or who have had a major part of the stomach surgically removed
• People with a fever above 38°C in the past week, or an active infection requiring treatment, including active tuberculosis or active fungal, bacterial, or viral infections
• People with active bleeding, a new blood clot condition, a tendency to bleed, or who are taking blood-thinning medication
• People with significant heart rhythm or conduction problems on a resting heart tracing, unstable chest pain, heart failure, or moderate-to-severe chronic heart failure (rated class 2 or higher on a standard heart failure scale)
• People who have had a heart attack, heart bypass surgery, or stroke within the past 3 months
• People with a prolonged heart electrical interval (QTc) on a 12-lead heart tracing — above 450ms for men or above 470ms for women
• People with risk factors that could further prolong this heart electrical interval, such as heart failure, significantly low potassium levels with symptoms requiring treatment, or a personal or family history of a specific heart condition called long QT syndrome
• People who have taken any medication known to prolong the QT interval within 2 weeks before joining
• People whose blood test results show that bone marrow function or organ function is below required levels across specific measures including white blood cell counts, platelet counts, haemoglobin, liver enzymes, bilirubin, kidney function, or protein levels (confirm specific thresholds with trial site)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People whom the research team assesses as otherwise unsuitable for the study for any reason

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