osteosarcoma
Conditions
Interventions
Experimental group:Methotrexate+Ifosfamide+Doxorubicin Hydrochloride Liposome Injection+Cisplatin
Control group:Methotrexate+Ifosfamide+Doxorubicin Hydrochloride+Cisplatin
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
10 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 10 to 65 years, gender is not limited; 2.Disease site: limbs; 3.Patients with classic osteosarcoma diagnosed as stage IIB-III by histopathological examination; 4.Have not received other anti-tumor therapy before, and according to the judgment of the investigator, it is expected to achieve standardized resection after receiving neoadjuvant therapy; 5.The patient's lesions can be measured, and the measurement standard refers to RECIST 1.1; 6.KPS>=70; 7.Expected survival period >= 6 months; 8.Heart function: (1)Left ventricular ejection fraction (LVEF) >= 50%; (2)EKG indicates no myocardial ischemia; (3)No history of arrhythmia requiring drug intervention before enrollment; 9.Bone marrow function: neutrophils (ANC) >=1.5x10^9/L, platelets (PLT) >=75x10^9/L, hemoglobin (HB) >=95g/L, white blood cells (WBC) >=3.0x10^9/L; 10.Liver and kidney function: serum creatinine (Cr) <= 2.0 times the upper limit of normal, AST and ALT <= 2.5 times the upper limit of normal, total bilirubin (TBIL) <= 2.5 times the upper limit of normal, or when the patient has Gilbert's syndrome <=2.5 times the upper limit of normal, blood urea nitrogen <=2.5 times the upper limit of normal; 11.Subjects of childbearing age must agree to take effective contraceptive measures during the trial; women of childbearing age must have a negative serum or urine pregnancy test; non-breastfeeding patients; 12.Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.The primary lesion has no pathological diagnosis; 2.Patients with pathological diagnosis of pelvic osteosarcoma, vertebral osteosarcoma, skull osteosarcoma, jaw osteosarcoma, multicentric osteosarcoma, axial osteosarcoma, and secondary osteosarcoma; 3.Participate in other clinical trials; 4.Patients who need to receive other anti-tumor therapy, including but not limited to traditional Chinese medicine therapy, anti-angiogenesis therapy, targeted therapy, etc.; 5.There are contraindications to chemotherapy, including but not limited to liver and renal insufficiency and other diseases, known to be allergic, highly sensitive or intolerable to research-related drugs or their excipients; 6.Other malignant tumors have occurred in the past 5 years, except for the cured cervical carcinoma in situ and non-melanoma skin cancer; 7.Serious infection (CTCAE>2 grade) occurred within 4 weeks before the first study administration; anti-infective treatment is required, including but not limited to patients with syphilis, HBV or HCV infection; 8.Previous or concomitant heart disease, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, arrhythmia (including persistent atrial fibrillation, complete left bundle branch obstruction) stagnation, frequent early morning); 9.People with a history of mental illness that is not easy to control; 10.Patients who are judged by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;Efficacy of neoadjuvant;Incidence and severity of adverse events;Life quality evaluation; | — |
Countries
China
Contacts
Public ContactNiu Xiaohui
Beijing Jishuitan Hospital
Outcome results
None listed