Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT06998758
Eligibility Criteria:
Inclusion Criteria:
* Adult males and females aged between 18 and 75 years old.
* Histologically confirmed colorectal adenocarcinoma.
* Immunohistochemistry showing pMMR or MSI status determined as MSS.
* Clinical stage cTxN1-2M0, with or without MRF positivity, and with or without EMVI positivity.
* ECOG performance status 0-1, with a life expectancy of ≥6 months.
* Deemed suitable for preoperative mFOLFOX6 neoadjuvant chemotherapy following multidisciplinary team discussion.
* Written informed consent has been obtained from the patients.
Exclusion Criteria:
* Patients with cardiac arrhythmias requiring anti-arrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure greater than NYHA Class II.
* Patients with poorly controlled severe hypertension.
* Patients with a history of HIV infection or active chronic hepatitis B or C (with high-copy viral DNA).
* Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
* Patients with other active severe clinical infections (per NCI-CTC v.5.0).
* Patients who have previously received chemotherapy.
* Patients with a history of seizures requiring treatment (e.g., steroids or anti-epileptic therapy).
* Patients with drug abuse or medical, psychological, or social conditions that may interfere with study participation or outcome assessment.
* Patients with a known or suspected allergy to the study drug or any agents administered in relation to the trial.
* Patients with any unstable condition that may jeopardize patient safety or compliance.
* Pregnant or breastfeeding women, or fertile women not using adequate contraception.
* Patients who refuse to sign the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06998758
Study Brief:
Protocol Section:
NCT06998758