Osteosarcoma
Conditions
Interventions
Control group:Patients with IV degree of granulocyte deficiency after chemotherapy are only given polyethylene glycolated recombinant human granulocyte stimulating factor injection and other symptomat
Test group:Patients with IV degree of granulocyte deficiency after chemotherapy were given polyethylene glycolated recombinant human granulocyte stimulating factor injection and other symptomatic trea
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 12-70 years old at the time of screening; 2. Patients with osteosarcoma receive neoadjuvant or adjuvant chemotherapy and develop IV granulocytopenia after chemotherapy, including prior to the evaluation of the screening period, with the written informed consent of the subject/legal representative; 3. The physical condition score of the Eastern Cancer Collaboration Group (ECOG) in the United States was 0-2 points; 4. Life expectancy = 6 months, and patients in hospital receiving chemotherapy in our department; 5. The cardiopulmonary function is basically normal;
Exclusion criteria
Exclusion criteria: 1. Subjects have clinical symptoms of central nervous system metastases (eg, cerebral edema, need for hormonal intervention, or brain metastases progress). Subjects who have previously received brain or meningeal metastases, such as clinical stabilization (MRI) for at least 2 months, and who have discontinued systemic hormone therapy (dose > 10 mg/day prednisone or other equivalent corticosteroid hormone) for more than 2 weeks, may be included; 2. The subject is using immunosuppressants, or systemic, or absorbable topical hormone therapy to achieve immunosuppressive purposes (dose > 10mg/day prednisone or other equivalent therapeutic hormones), and continues to use it within 2 weeks before enrollment; 3. The subject is using immunomodulatory drugs and continues to use them for 2 weeks before enrollment; 4. The subject has any active autoimmune disease or has a history of autoimmune disease; 5. The subject has active tuberculosis; 6. The subject has hepatitis C or HIV infection, or syphilis infection; 7. According to the judgment of the researchers, the subjects have other factors that may lead to termination in the middle of the process, such as other serious diseases (including mental illness) that require co-treatment, serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of test data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days required for granulocyte recovery to =1.5× 109/ L after treatment, the minimum value of leukocyte and granulocyte decline;Whether the patient developed fever and other infections, and the recovery time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of granulocyte and leukocyte in two groups before and after treatment;Granulocytes <0.5× 109 / L occurred several days after chemotherapy and lasted for several days;Whether there were still granulocytes <1.5× 109 / L on the 21st day after the end of chemotherapy, and whether the drug was stopped or reduced in the next chemotherapy cycle; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Shanghai Sixth People's Hospital
Outcome results
None listed