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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT06930118
Eligibility Criteria:
Inclusion Criteria:
* Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology;
* Those who have experienced disease progression or are intolerant to treatment after receiving ≥ 2 lines of systemic standard therapy;
* Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
* Patients who have received local radiotherapy at least 3 weeks before the first drug treatment are eligible for inclusion; however, the lesions evaluated by RECIST must not be within the radiotherapy field;
* Patients must be at least 18 years old;
* Performance status ECOG score of 0-1;
* Expected survival ≥ 12 weeks;
* Patients must have the ability to understand and voluntarily sign the written informed consent form;
* Women of childbearing age must have a negative pregnancy test within 7 days before the start of treatment. During the study period, both the patient and the patient's spouse must take contraceptive measures.
Exclusion Criteria:
* Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug;
* Patients with hypersensitivity to any component of the study protocol;
* Patients planning to conceive or who are pregnant;
* Patients with brain metastases and an inability to accurately describe their condition;
* Patients who have experienced any of the following diseases within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher congestive heart failure, uncontrolled arrhythmia, etc.;
* Abnormal laboratory tests:
Absolute neutrophil count (ANC) \< 1,500/mm3; Platelet count \< 75,000/mm3; Total bilirubin \> 1.5 times the upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal (for patients with liver metastases \> 5 times the upper limit of normal); Creatinine \> 1.5 times the upper limit of normal;
* Patients who have had other cancers (except advanced colorectal cancer) within 5 years prior to the start of this study treatment. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors are excluded;
* Patients with a history of drug abuse, drug addiction, or alcohol dependence;
* Patients without legal capacity or with limited civil capacity;
* Other conditions that the investigator deems inappropriate for inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06930118
Study Brief:
Protocol Section:
NCT06930118