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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT03412994
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 18 to 70 years old;
2. Histologically or cytologically proven patients with metastatic colorectal cancer have undergone a first-line standard regimen recommended by the NCCN guidelines for progression;
3. According to the RECIST 1.1 criteria, the patient has at least one target lesion that can measure the diameter;
4. ECOG PS ≤ 2;
5. Expected survival time of more than 12 weeks.
6. The level of organ function must meet the following requirements:
Bone marrow: neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet ≥ 75 × 10\^9/L, hemoglobin ≥ 90g/L.
Liver: serum bilirubin ≤ 2 times the upper limit of normal, aminotransferase AST and ALT ≤ 2.5 times the normal upper limit.
Kidney: Serum creatinine ≤1.5 times upper limit of normal.
7. Patient compliance is good;
8. Understand and voluntarily sign a written informed consent.
Exclusion Criteria:
1. Other previous or concurrent malignancy, except cured skin basal cell carcinoma and cervical carcinoma in situ;
2. Already known to be allergic to apatinib or any excipient;
3. Use unapproved drugs or other test medications within 4 weeks prior to enrollment;
4. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction);
5. Patients with a history of CNS metastases or CNS metastases;
6. A history of bleeding, with any serious grading within 4 weeks prior to screening reaching a bleeding event of 3 degrees Celsius or greater in CTCAE4.0;
7. Serious infection;
8. Serious cardiovascular disease: uncontrolled hypertension, unstable angina, grade 3-4 heart failure (NYHA standard), congestive heart failure;
9. urinary routine urinary protein ≥ ++ and confirmed 24-hour urinary protein quantitation\> 1.0 g;
10. Within 30 days after major surgery;
11. Thrombotic disease. Anemia or venous thrombosis occurred in the previous year, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, etc.;
12. Those with history of psychotropic substance abuse who can not be abstinent or have mental disorders;
13. Have clinical symptoms, need clinical intervention pleural effusion or ascites;
14. At the investigator's discretion, there is a serious concomitant condition that compromises the patient's safety or affects the patient in completing the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03412994
Study Brief:
Protocol Section:
NCT03412994