Last updated: April 2, 2021
Sponsor: Beijing Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Neoplasm Metastasis
Neuroblastoma
Treatment
N/AClinical Study ID
NCT04832204
BeijingHY2020-02-07
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- age: ≥18 years old, both male and female;
- after pathological diagnosis and first-line treatment failure of advanced solid tumorwith liver metastasis only after consultation by MDT team, the patient had measurablelesions (helical CT scan ≥10mm, meeting the RECIST 1.1 standard);
- ECOG PS: 0 ~ 1;
- subjects' baseline blood routine and biochemical indicators shall meet the followingstandards: 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 timesnormal upper limit Serum total bilirubin ≤1.5 times normal upper limit, Serumcreatinine ≤1.5 times normal upper limit, Serum albumin ≥30g/L;
- expected survival period ≥3 months; 7) women of child-bearing age must undergo apregnancy test (serum or urine) within 7 days prior to enrollment and the result isnegative, and be willing to use appropriate methods of contraception during the trial and 8weeks after the last dose of the test drug.For men, either surgical sterilization orconsent to appropriate methods of contraception during the trial and 8 weeks after the lastadministration of the trial drug; 8) subjects voluntarily joined the study and signed theinformed consent, with good compliance and follow-up.
Exclusion
Exclusion Criteria:
- proven allergic to apatinib and/or its excipients;
- patients with hypertension and unable to reduce to the normal range afterantihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic bloodpressure >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) andgrade I cardiac dysfunction;Patients with positive urinary protein;
- there are multiple factors affecting oral drugs (such as inability to swallow, nausea,vomiting, chronic diarrhea and intestinal obstruction, etc.);
- 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;Ahistory of black stool or hematemesis within 2 months;For patients with fecal occultblood (+) and no surgical resection of the primary gastric tumor, gastroscopy isrequired.
- abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency;
- patients with central nervous system metastasis;
- pregnant or nursing women;
- patients with other malignant tumors within 5 years;
- patients who have a history of psychotropic substance abuse and cannot be cured orhave mental disorders;
- patients who have participated in clinical trials of other drugs within 4 weeks;
- according to the judgment of the researcher, patients with concomitant diseases thatseriously endanger the safety of patients or affect the completion of the study;
- not suitable for inclusion.
Study Design
Total Participants: 20
Study Start date:
March 25, 2021
Estimated Completion Date:
April 30, 2024
Study Description
Connect with a study center
Beijing Hospital
Beijing, Beijing 100730
ChinaSite Not Available

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