head and neck sarcoma
Conditions
Interventions
Experimental group:2 cycles of neoadjuvant therapy with anlotinib
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
10 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 10-75 years, no gender limit; 2. The patient's ECOG PS (performance status,) score was no more than 2 points, and the expected survival time was more than 3 months; 3. Patients with locally advanced inoperable sarcoma with planned surgery, histological or cytological evidence of head and neck sarcoma (inoperable including tumor lesions that cannot be surgically removed); Mainly included patients with soft tissue sarcoma and osteosarcoma (except embryonal rhabdomyosarcoma); 4. According to Recist version 1.1, there is at least one measurable lesion; 5. The TNM stage was ?-?, but there was no distant metastasis; 6. Not accompanied by any other anticancer therapy; 7. Not accompanied by using a daily dose of 20 mg or methyl prednisolone or dose equivalent long-term corticosteroid treatment (3 months) or higher; 8. If the major organs are functioning normally, the following criteria are met: (1) The standard of blood routine examination shall meet: (no blood transfusion within 14 days) HB >= 90g/L; ANC >= 1.5x10^9/L; PLT >= 80x10^9/L; (2) Biochemical examination should meet the following criteria: bilirubin BIL = the lower limit of normal value (50%); 9. Women should agree to use contraception during the study period and for six months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should consent to patients who must use contraception during the study period and for 6 months after the study period ends; 10. The patients voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up visits; Patients whom doctors believe will benefit from treatment.
Exclusion criteria
Exclusion criteria: 1. Previously received vascular endothelial growth inhibitors (such as Sunitinib, sorafenib, bevacizumab, imatinib, Apatinib, etc.). 2. Past or concurrent with other malignant tumors. 3. Participated in clinical trials of other drugs within 6 months. 4. Patients with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction). 5. Known spinal cord compression, cancerous meningitis, or brain or pia disease detected by CT or MRI during screening. 6. Patients with any severe and/or uncontrolled medical conditions, such as: (1) Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, and severe uncontrolled arrhythmia; Patients with poor blood pressure control (systolic > 140mmHg, diastolic > 90mmHg); (2) Active or uncontrolled severe infection; (3) Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L); (5) Urine routine indicated urine protein >=++, and confirmed 24 hours urine protein quantity > 1.0g. 7. A wound or fracture that hasn't healed for a long time. 8. Patients with bleeding tendencies (such as active digestive ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogitics. 9. Patients with a history of arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, before initial medication. 10. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders. 11. Patients with a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation. 12. Pregnant or lactating patients. 13. Patients with other concomitant diseases that, in the investigator's judgment, seriously endanger the patient's safety or interfere with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local response rate after drug treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor complete response rate;Tumor response rate; | — |
Countries
China
Contacts
Public ContactJi Tong
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed