chordoma
Conditions
Interventions
Case series:Apatinib
Sponsors
Shanghai Changzheng hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18 years to 75 years old, men and women are not limited; 2. chordoma recurrence by histopathology and / or cytology after operation with measurable lesions (spiral CT scan is more than 10mm, meet the RECIST standard 1.1); 3. previous surgical treatment of tumor resection; 4. patients have therapeutic indications; 5. the main organ function is normal, conforming to the following requirements: (1) blood routine examination, should be conformed (no blood transfusion within 14 days): HB = 90g/L; ANC = 1.5*10^9/L; PLT = 80*10^9/L. (2) biochemical examination should comply with the following criteria: The upper limit of normal value of BIL <1.5 times (ULN), ALT and AST<2.5 x ULN; if liver metastases, ALT and AST<5 x ULN; Serum Cr less than 1*ULN, creatinine clearance rate was higher than 50ml/min (Cockcroft-Gault formula) 6. the expected survival time more than 3 months; 7. the doctor plans to use the mesylate tablets in the treatment of apatinib; 8. patients volunteered to join the study and signed the informed consent (ICF); 9. women of childbearing age must be a pregnancy test in 7 days before entering the group (in serum or urine) were negative, and voluntary during the observation period, and the last piece of apatinib given appropriate methods within 8 weeks after using contraception; for men, for surgical sterilization, or consent during the observation period, and the last time for APA erlotinib tablets proper methods within 8 weeks after using contraception.
Exclusion criteria
Exclusion criteria: 1. patients with hypertension, the antihypertensive drug treatment can not be reduced to the normal range (>140 mmHg systolic / diastolic blood pressure > 90 mmHg), suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation > 450 ms male, female, 470 MS) and heart failure; 2. a variety of factors that affect the absorption of oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 3. VEGFR inhibitors, such as Sola Fini and suneinib, were treated. 4. abnormal coagulation function (INR>1.5 x ULN, APTT>1.5 x ULN), with bleeding tendency; 5. metastases of the central nervous system with symptoms; 6. pregnant or lactating women; 7. patients with coronary heart disease above I and arrhythmia (including QTc interval prolongation of male >450ms, female >470ms) and cardiac insufficiency; 8. patients with a history of psychotropic drug abuse and inability to abstinence or mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;progression free survival;life quality score;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| the safety;adverse event, AE; | — |
Countries
China
Contacts
Public ContactCheng Yang
Shanghai Changzheng hospital
Outcome results
None listed