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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT04131803
Eligibility Criteria:
Inclusion criteria:
1. Age ≥18 years and ≤75 years
2. Histologically and radiologically confirmed colorectal adenocarcinomaImaging and/or pathology confirmed the presence of distal metastases
3. Multidisciplinary team (MDT) identifies unresectable metastatic colorectal cancer (mCRC)
4. RAS and BRAF genes are wild-type
5. The patient had no previous treatment for mCRC, including chemotherapy, surgery, radiotherapy, hepatic artery chemoembolization (TACE) and targeted therapy
6. Hematological function was normal (platelet \> 90×109/L; White blood cell \> 3×109/L; Neutrophil \> 1.5×109/L)
7. Serum bilirubin ≤1.5 times the upper normal value (ULN), transaminase ≤5 times ULN
8. No ascites, normal coagulation function, albumin ≥35g/L
9. Child-push liver function was rated A
10. Serum creatinine is below the upper normal limit (ULN) or the calculated creatinine clearance rate of \> 50ml/min (using Cockcroft-Gault formula)
11. ECOG score 2-0
12. Life expectancy \> 3 months
13. Sign written informed consent
14. Willing and able to receive follow-up until death or study completion or study termination
Exclusion criteria:
Patients who meet any of the following criteria will be excluded from the study:
1. Recurrence of primary tumor
2. Severe arterial embolism or ascites
3. A tendency to bleed or clotting disorder
4. Hypertensive crisis or hypertensive encephalopathy
5. Severe uncontrolled systemic complications such as infection or diabetes
6. Clinically serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension after appropriate drug treatment, unstable angina, congestive heart failure (nyha2-4), and arrhythmia requiring drug treatment
7. History of central nervous system disease (e.g. primary brain tumor, epilepsy beyond the control of standard treatment, any brain metastasis or stroke)
8. Other malignancies in the past 5 years (except basal cell carcinoma of skin and/or cervical carcinoma in situ after radical resection)
9. Received any drug under study or treatment with the same type of drug in the last 28 days before the study
10. Any residual toxicity from previous chemotherapy (except hair loss), such as peripheral neuropathy ≥NCI CTC v3.0 standard level 2
11. Is allergic to any of the drugs in the study
12. Pregnant and lactating women
13. Inability or unwillingness to comply with research protocols
14. The presence of any other disease, dysfunction due to metastatic lesions, or a suspected medical condition indicated a possible contraindication to the use of the study drug or a population at high risk for treatment-related complications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04131803
Study Brief:
Protocol Section:
NCT04131803