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Clinical trial of secondary prevention of recombinant human thrombopoietin in the prevention of thrombocytopenia in advanced osteosarcoma with apatinib and docetaxel

Clinical trial of secondary prevention of recombinant human thrombopoietin in the prevention of thrombocytopenia in advanced osteosarcoma with apatinib and docetaxel

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016838
Enrollment
Unknown
Registered
2018-06-28
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thrombocytopenia in advanced osteosarcoma

Interventions

Case series:rhTPO

Sponsors

Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
thrombocyte;

Countries

China

Contacts

Public ContactHu Haiyan

Affiliated Sixth People's Hospital, Shanghai Jiaotong University

xuri1104@163.com+86 18930174575

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026