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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT04912258
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Histologically proven colorectal liver metastasis；
* With liver-dominant disease；
* Primarily evaluated as potentially resectable and conversed successfully
* Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 (within 1 week prior to randomization)
* Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization);
* Written informed consent for participation in the trial.
Exclusion Criteria:
* Primarily evaluated as resectable
* Failed to converse
* Patients with known hypersensitivity reactions to any of the components of the study treatments.
* Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
* Other previous malignancy within 5 years
* Known drug abuse/ alcohol abuse
* Legal incapacity or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04912258
Study Brief:
Protocol Section:
NCT04912258