Osteosarcoma
Conditions
Interventions
Treatment group:Apatinib mesylate tablets combined with chemotherapy
Sponsors
Department of Orthopedics Oncology, Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed written informed consent, had good compliance, and cooperated with the follow-up; 2. Age >= 40 years old, male or female; 3. Patients with stage IIB and III osteosarcomas confirmed by histopathology and/or cytology have measurable lesions (spiral CT scan or MRI measurement >= 10mm, meeting RECIST 1.1 standard); 4. Osteosarcoma patients who have not received anti-tumor treatment in the past; 5. The patient has treatment indications and plans to undergo surgery after neoadjuvant chemotherapy; 6. The physical fitness score of the eastern cancer cooperation group (ECoG) is 0-2; 7. The functions of the main organs are normal and meet the following requirements: (1) Blood routine examination should meet the following requirements (no blood transfusion within 14 days): 1) HB >= 90g/L; 2) ANC >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; (2) 1) Bil = 50ml / min (Cockcroft Gault formula); 4) Serum albumin >= 30 g / L; 8. Estimated survival period >= 6 months; 9. The patients voluntarily joined the study and signed the informed consent form (ICF); 10. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate methods of contraception during the observation period and within 90 days after the last administration of apatinib tablets; For men, they should be sterilized surgically, or they should agree to use appropriate methods of contraception during the observation period and within 90 days after the last administration of apatinib tablets.
Exclusion criteria
Exclusion criteria: 1. Patients who have received radiotherapy, chemotherapy, targeted therapy, immunotherapy, traditional Chinese medicine and other anti-tumor treatment after diagnosis; 2. Have hypertension and cannot be well controlled by antihypertensive drugs (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 3. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) heart failure above NYHA grade 2; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; (5) Qtc>450ms (male); Qtc>470ms (female); (6) Cardiac color Doppler ejection fraction EF 2.0, pt>16s), bleeding tendency or being treated with thrombolysis or anticoagulation, and the preventive use of low-dose aspirin and low-molecular-weight heparin is allowed; 7. Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.); 8. Before starting treatment, it has not fully recovered from the toxicity and / or complications caused by any intervention (i.e. <= CTCAE level 1 or reaching the baseline, excluding hair loss); 9. Symptomatic central nervous system metastasis; 10. Lactating women; 11. Patients with congenital or acquired immune function defects (such as people infected with HIV); 12. Patients who have a history of psychotropic substance abuse and cannot quit or have mental disorders; 13. The patient has severe mucosal ulcer, wound, sinus, tumor rupture, or continuous nonunion of biopsy channel; 14. Other researchers believe that there are circumstances unsuitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor necrosis rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival,EFS;Overall Survival,OS;Objective remission rate,ORR;Disease control rate,DCR;Quality of life score; | — |
Countries
China
Contacts
Public ContactCheng Yang, Jianru Xiao
Outcome results
None listed