Bone and soft tissue sarcoma
Conditions
Interventions
Phase 1: Control group:Patients with bone and soft tissue sarcoma who had IV-degree bone marrow suppression in previous chemotherapy did not receive Turacilli for preventive treatment.
Phase 1: Experimental group:Patients with bone and soft tissue sarcoma who have experienced IV-degree bone marrow inhibition in chemotherapy should receive trarasili (240 mg/m2, intravenous administra
Phase 2: Control group:Patients with bone and soft tissue sarcoma will not receive prophylactic treatment until they plan to receive a high-risk chemotherapy regimen.
Phase 2: Experimental group:Before patients with bone and soft tissue sarcoma are proposed to receive high-FN-risk chemotherapy, trarasili (240 mg/m2, intravenous administration within 4 hours before
Sponsors
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: a) Age 12-70 years old at the time of screening, both male and female; b) histologically and pathologically confirmed bone and soft tissue sarcoma: Stage I: IV degree myelosuppression with prior chemotherapy; Stage 2: Chemotherapy with a high risk of FN; c) voluntarily participate in this study with the written informed consent of the subject/legal representative; d) Eastern Oncology Group (ECOG) physical status score of 0-2; e) Life expectancy= 3 months; f) have a good level of organ function; Bone marrow function needs to meet: neutrophil count (ANC) = 1.5×109/L; Platelet count (PLT) =100×109/L; hemoglobin (Hb) =9g/dL; Renal function serum creatinine (Cr) = 1.5 times the upper limit of normal value or creatinine clearance = 50ml/min; Liver function: total bilirubin < 1.5 x ULN (< 2.0 x ULN for subjects with documented Gilbert syndrome or 3<.0 x ULN for subjects with indirect bilirubin levels suggestive of extrahepatic elevated source); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN if liver metastases occur); Coagulation function: prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), or international normalized ratio (INR) <1.5 or within the target range (if prophylactic anticoagulation is performed); g) Female patients need a negative pregnancy test; h) No birth plan for 3 years, use contraception.
Exclusion criteria
Exclusion criteria: a) Participants with clinically symptomatic central nervous system metastases (e.g., cerebral oedema, need for hormonal intervention, or progression of brain metastases). Participants who have previously received treatment for brain or meningeal metastases, if clinically stable (MRI) has been maintained for at least 2 months, and have stopped systemic hormone therapy (dose > 10 mg/day prednisone or other effective hormones) for more than 2 weeks can be included; b) Subject is using immunosuppressants, or systemic or absorbable topical hormone therapy for immunosuppressive purposes (dose> 10mg/day prednisone or other effective hormones) and continues to use it within 2 weeks prior to enrollment; c) Those who must take drugs that cause bone marrow suppression due to other medical conditions; d) Those with previous chronic blood diseases; e) Other chronic bleeding; f) Subject has any active autoimmune disease or has a history of autoimmune disease; g) participants have active tuberculosis; h) the subject had hepatitis C or HIV infection, or syphilis infection; i) patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure = 150 mmHg, diastolic blood pressure =100 mmHg); Have grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QTc =480ms), and grade =2 congestive heart failure (New York Heart Association (NYHA) grade); j) According to the judgment of the researcher, the subject has other factors that may lead to the termination of the process, such as other serious diseases (including mental illness) that require combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of test data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of recurrence of severe (grade 4) neutrophytes (DSN); the percentage of patients with severe neutrophytes (SN) during treatment. SN is defined as the absolute number of neutrophils <0.5×109/L;Duration of severe (level 4) neutropenia (DSN) in the first cycle; the percentage of patients with severe neutrophilia (SN) during treatment. SN is defined as the absolute number of neutrophils <0.5×109/L.;Incidence of erythrocyte transfusion and platelet transfusion;Whether the patient has fever and the severity of infection, and the recovery time;Safety assessment: TEAEs and new safety; incidence of chemotherapy exposure, dose reduction and dose interruption; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of 3/4 thrombocytopenia during treatment, duration of 3/4 thrombocytopenia;The incidence of grade 3/4 anemia during treatment;Use of G-CSF, ESA, TPO and IL-11 during treatment;Incidence of erythrocyte transfusion and platelet transfusion;Whether the patient has fever and the severity of infection, and the recovery time;Safety assessment: TEAEs and new safety; incidence of chemotherapy exposure, dose reduction and dose interruption;The incidence of 3/4 thrombocytopenia during treatment, duration of 3/4 thrombocytopenia;The incidence of grade 3/4 anemia during treatment;Use of G-CSF, ESA, TPO and IL-11 during treatment; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Outcome results
None listed