recurrent/metastatic soft tissue sarcoma
Conditions
Sponsors
The Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects were willing to join in this study, sign the informed consent, good adherence, and cooperate with the follow-up; 2. Aged 18 to 70 years; ECOG score=2; 3. Histological diagnosed soft tissue sarcoma; 4. pathology or clinical diagnosis of recurrence and distant metastasis, after at least one treatment of disease progress; 5. According to RECIST version 1.1 standard (appendix), the patient has at least one extracranial measurable lesions,(Spiral CT scans =10 mm, CT scanning layer is not more than 5 mm thick), it can be measured that lesions has not received radiotherapy; 6. Expected lifetime acuity = 3 months; 7. Normal function of major organs should meet the following criteria: (1) the blood routine examination must be in accordance with standard: 1) HB=90 g/L (14 days without blood transfusion); 2) ANC=1.5×10^9/L; 3) PLT=80×10^9/L; (2) the biochemical examination must be in accordance with the following criteria: 1) TBIL=1.5×ULN (higher than the normal limit); 2) ALT and AST=2.5×ULNif has liver metastasis ALT and AST=5×ULN; 3) Serum Cr=1×ULN the endogenous creatinine clearance>50 ml/min (Cockcroft-Gault formula); 8. Women or men of childbearing age are willing to using appropriate methods of contraception during the test and six months after having the last experimental drug. Women of childbearing age should have a pregnancy check before test if necessary, and the result should be negative.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously used the apatinib; 2. Always use a VEGFR, PDGFR and s - SRC kinase inhibitor drugs therapy; 4 weeks prior to the start of the study involved in other drug clinical trial; 3. The past five years has a history of other malignant tumors, but has been cured except skin basal cell carcinoma and cervical carcinoma in situ; 4. Have high blood pressure and the single antihypertensive drug treatment can't obtain good control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-I myocardial ischemia or myocardial infarctionwith level-I arrhythmia (including QT interval=440 ms) or cardiac insufficiency; 5. The influence of oral drugs and absorption of a variety of factors (Such as unable to swallow, after resection of gastrointestinal tract, chronic diarrhea and intestinal obstruction); 6. Coagulant function abnormality, was treated with thrombolysis or anticoagulation, with a bleeding tendency or there are clear gastrointestinal bleeding concerns, (such as: there are local active ulcer lesions, defecate occult blood as positive); 7. A period of 6 months prior to the start of the study dynamic/enous thromboembolism event has occurred, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc; 8. Long term with chest and other parts of the wound or fracture; 9. Routine urine prompt urinary protein>++and 24 hours urinary protein quantitative>1.0 g; 10. There are serious or not controlled infection; 11. Has a history of psychiatric drugs abuse and can't quit or has a history of mental disorders; 12. The patients has a objective evidence of past and present medical history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, pulmonary function was seriously damaged; 13. A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 14. Hepatitis b viral hepatitis (except the activity carriers) or hepatitis c patients; 15. Clinical trials of other anti-tumor drugs have been performed in four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactYongkui Lu
The Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed