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:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT04509635
Eligibility Criteria:
Inclusion Criteria:
1. Primary tumour was histologically confirmed colorectal adenocarcinoma;
2. Clinical or radiological evidence of non-resectable liver metastases;
3. With at least one measurable tumor;
4. Received first-line cetuximab (RAS gene wild type) treatment and progressed
5. Received second-line non-cetuximab treatment and progressed
6. Received circulating tumor DNA test and has RAS gene wild type status;
7. Performance status (ECOG) 0\~1
8. A life expectancy of ≥ 3 months
9. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
10. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 5 x ULN(within 1 week prior to randomization);
11. Written informed consent for participation in the trial.
Exclusion Criteria:
1. Patients with known hypersensitivity reactions to any of the components of the study treatments.
2. Acute or sub-acute intestinal occlusion
3. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
4. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Known drug abuse/ alcohol abuse
5. Legal incapacity or limited legal capacity
6. Pre-existing peripheral neuropathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04509635
Study Brief:
Protocol Section:
NCT04509635