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 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT04832204
Eligibility Criteria:
Inclusion Criteria:
1. age: ≥18 years old, both male and female;
2. after pathological diagnosis and first-line treatment failure of advanced solid tumor with liver metastasis only after consultation by MDT team, the patient had measurable lesions (helical CT scan ≥10mm, meeting the RECIST 1.1 standard);
3. ECOG PS: 0 \~ 1;
4. subjects' baseline blood routine and biochemical indicators shall meet the following standards: Hemoglobin ≥80g/L, Absolute neutrophils count (ANC) ≥1.5×109/L, Platelet ≥90×109/L, ALT and AST≤2.5 times normal upper limit, and liver metastasis ≤5 times normal upper limit Serum total bilirubin ≤1.5 times normal upper limit, Serum creatinine ≤1.5 times normal upper limit, Serum albumin ≥30g/L;
6\) expected survival period ≥3 months; 7) women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the result is negative, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose of the test drug.For men, either surgical sterilization or consent to appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; 8) subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion Criteria:
1. proven allergic to apatinib and/or its excipients;
2. patients with hypertension and unable to reduce to the normal range after antihypertensive drug treatment (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg), coronary heart disease at or above grade I, grade I arrhythmia (including QTc interphase prolonging \> 450 ms in males and \> 470 ms in females) and grade I cardiac dysfunction;Patients with positive urinary protein;
3. there are multiple factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
4. patients with a clear tendency of gastrointestinal bleeding, including the following: local active ulcer lesions, and fecal occult blood (++) is not included in the group;A history of black stool or hematemesis within 2 months;For patients with fecal occult blood (+) and no surgical resection of the primary gastric tumor, gastroscopy is required.
5. abnormal coagulation function (INR\>1.5, APTT\>1.5 ULN), with bleeding tendency;
6. patients with central nervous system metastasis;
7. pregnant or nursing women;
8. patients with other malignant tumors within 5 years;
9. patients who have a history of psychotropic substance abuse and cannot be cured or have mental disorders;
10. patients who have participated in clinical trials of other drugs within 4 weeks;
11. according to the judgment of the researcher, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study;
12. not suitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04832204
Study Brief:
Protocol Section:
NCT04832204