Head neck sarcoma
Conditions
Interventions
experimental group:Antinib hydrochloride capsule
Sponsors
Shanghai Ninth People's Hospital
Eligibility
Sex/Gender
All
Age
10 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: >= 10 years old, = 20mg per day or corticosteroid of the same dose (>= 3 months) should not be accompanied; 9. The main organs function normally, i.e. they meet the following criteria: (1) blood routine examination standards shall meet :(no blood transfusion within 14 days) A. HB >= 90 g/L B. ANC >= 1.5 x 10^9 / L; C. PLT >= 80 x 10^9 / L or higher (2) Biochemical examination shall meet the following standards: A. IL 50ml/min (Cockcroft-Gault formula) D. Fasting triglyceride = lower normal limit (50%). 10. Women should agree to use contraception during the study period and for a period of six months after the study; Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Men should agree to use contraception during the study period and for six months after the end of the study period. 11. Subjects voluntarily participate in this study, sign informed consent, have good compliance and cooperate with follow-up; 12. Doctors believe that patients can benefit from treatment.
Exclusion criteria
Exclusion criteria: 1. Previous treatment, including vascular endothelial growth inhibitors (such as sunitinib, sorafenib, bevacizumab, imatinib, apatinib and other drugs), as well as systematic chemotherapy and radiotherapy for the patients. 2. Previous or concurrent presence of other malignant tumors. 3. Participated in other drug clinical trials within 6 months. 4. Multiple factors affecting oral medication (such as inability to swallow, post-gi resection, chronic diarrhea, and ileus). 5. Known brain metastasis, spinal cord compression, cancerous meningitis, or diseases of the brain or pia meninges detected by CT or MRI during screening. 6. Patients with any severe and/or uncontrolled disease such as: 1) Unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, and severe uncontrolled arrhythmias; Patients with poor blood pressure control (systolic bp > 140mmHg, diastolic bp > 90mmHg); 2) Active or uncontrolled severe infection; 3) Liver diseases such as cirrhosis, decompensated liver disease, and chronic active hepatitis; 4) poor control of diabetes mellitus (FBG) > 10mmol/L;5) urine routine indicated urinary protein >= ++, and confirmed 24-hour quantitative urinary protein > 1.0g; 7. A wound or fracture that has not been healed for a long time. 8. Patients with bleeding tendencies (e.g., active gastrointestinal ulcers) or those treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs. 9. Prior to the first administration of the drug, patients had experienced ARTERiovenous thrombosis (AVT), such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (DVT) and pulmonary embolism.10. Those who have a history of abuse of psychotropic substances and cannot be cured or have mental disorders. 11. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 12. Pregnant or lactating women. 13. Patients with other concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate of tumor; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactTong Ji
Shanghai Ninth People's Hospital
Outcome results
None listed