thrombocytopenia in advanced osteosarcoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with advanced osteosarcoma treated with apatinib plus docetaxel; 2. The body surface area of patients aged 14-70 years and 60 points; 5. The main organ function meets the following criteria within 7 days before treatment: Blood test standard (without blood transfusion within 14 days): Hemoglobin (HB) = 90g/L (patients with anemia due to multiple metastasis of the tumor, haemoglobin =85g/L); Neutrophil absolute (NEU) = 1.5×10^9/L; Biochemical tests must meet the following criteria: total bilirubin (TBIL) = 1.5 ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 ULN, and with liver metastasis, ALT and AST = 5 ULN; serum creatinine (Cr) = 1.5 ULN or creatinine clearance (CCr) = 60 ml/min; Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = normal lower limit (50%). 6. Expected survival period = 3 months; 7. Patients voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Accompanied with pleural effusion effusion / ascitic fluid reaching more than 800ml or pleural effusion / ascites leading to respiratory syndrome (according to NCI CTC AE4.03 grade = 2 dyspnea. [Level 2 dyspnea refers to shortness of breath during a small amount of activity; impact on instrumental activities of daily living]]; 2. Except for intra-cervical in-situ cancer, non-melanoma skin cancer, and superficial bladder tumors that have occurred or currently have other malignant tumors within 5 years, [Ta (non-invasive) tumors, Tis (in situ cancer) ) and T1 (tumor infiltrating basement membrane)]; 3. Patients with brain metastases who have symptoms or symptoms for less than 2 months; 4. Patients with any severe and/or uncontrolled disease, including: (1) patients with unsatisfactory blood pressure control (systolic blood pressure = 150 mmHg, diastolic blood pressure = 100 mmHg); (2) having grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc = 480 ms) and = grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) active or uncontrollable serious infection (=CTC AE Level 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) have a history of immunodeficiency, including those who are HIV positive or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; (7) poorly controlled diabetes (fasting blood glucose (FBG)> 10 mmol/L); (8) Urinary cues suggest urinary protein = ++, and those who confirm 24-hour urine protein quantification> 1.0 g; (9) Patients with seizures and in need of treatment; 5. Patients with tumor thrombi; 6. patients with a single tumor longer than 20cm; 7. Those who have a history of psychotropic substance abuse and are unable to get rid of or have mental disorders; 8. Those who have a history of alcohol dependence and abuse and are unable to quit; 9. Have participated in clinical trials of other anti-cancer drugs within four weeks; 10. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| thrombocyte; | — |
Countries
China
Contacts
Affiliated Sixth People's Hospital, Shanghai Jiaotong University