Anrotinib Hydrochloride Combined With Adriamycin for Neoadjuvant Treatment of High-grade Soft Tissue Sarcoma

Inclusion Criteria:

1. Age: 18-65 years old, regardless of gender.
2. Patients with soft tissue sarcomas of trunk or limbs of G3 confirmed by histology orcytology; Pathological types include synovial sarcoma, undifferentiated pleomorphicsarcoma, leiomyosarcoma and fibrosarcoma.
3. No treatment with anthracyclines or anti-angiogenic targeted drugs.
4. According to RECIST Version 1.1 (Annex 1), there were measurable lesions at baselinewith primary tumors larger than 5cm and poor location in deep fascia;
5. ECOG Physical status score (Annex 2) a is 0-2, and the expected survival period ismore than 6 months.
6. Recovery from previous treatment: According to NCI-CTCAE version 5.0, all side effects (except hair loss) resolved to grade 1 or below.
7. If the major organs are functioning normally, the following criteria are met: Hemoglobin (Hb) ≥ 95g/L, Neutrophil (ANC) ≥1.5×109/L, Platelet count (PLT) ≥ 80×109/L,Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN), blood urea nitrogen (BUN) ≤ 2.5× upper limit of normal (ULN); Total bilirubin (TB) ≤ 1.5ULN; Aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; Albumin (ALB) ≥ 35 g/L Prothrombintime (PT) and partial prothrombin time (PTT) ≤1.2×ULN Left ventricular ejectionfraction ≥50% Blood pressure was controlled within 140/90 mmHg before enrollment
8. Women of childbearing age must have been using reliable contraception or have had apregnancy test (serum or urine) with negative results within 7 days prior to inclusionand be willing to use an appropriate method of contraception during the trial periodand 8 weeks after the last test drug administration. For men, consent is required touse an appropriate method of contraception or to have been surgically sterilizedduring the trial period and within 8 weeks after the last administration of the trialdrug
9. Sign an informed consent form (or legal representative sign) to demonstrate that theyunderstand the purpose of the study and the procedures required by the Institute, andare willing to participate in the study.

Exclusion Criteria:

1. Previous exposure to antirotinib hydrochloride or other small molecule anti-angiogenicTKI drugs, or anti-angiogenic mab drugs (such as Sunitinib, Sorafenib, bevacizumab,imatinib, Famitinib, Apatinib, Regafenib, etc.).
2. Systemic antitumor therapy, including cytotoxic therapy, signal transductioninhibitors, immunotherapy (or mitomycin C within 6 weeks prior to treatment with theexperimental drug) was planned for 4 weeks prior to enrollment or during themedication period of this study. Over extended field radiotherapy (EF-RT) wasperformed within 4 weeks prior to enrollment.
3. Other malignant neoplasms (other than squamous cell carcinoma of skin) in the past 3years;
4. Imaging (CT or MRI) showed that the tumor lesions had tumors invading local greatvessels, or were accompanied by tumor thrombus formation of large veins (iliacvessels, inferior vena cava, pulmonary veins, superior vena cava);
5. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis requireantiviral therapy;
6. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic bloodpressure ≥90 mmHg, despite optimal medical treatment);
7. Urine routine indicated urine protein ≥ ++, or confirmed 24 hours urine protein volume ≥1.0 g, urine protein/creatinine ≥1;
8. Uncontrolled co-morbidity, including, but not limited to, poorly controlled diabetes,persistent active infections, or mental illness or social conditions that may affectstudy compliance;
9. Abnormal coagulation function (INR > 1.5 or PT >1.2 ULN or PTT >1.2 ULN), bleedingtendency or receiving thrombolytic or anticoagulant therapy; Patients treated withanticoagulants or vitamin K antagonists such as warfarin, heparin, or theirequivalents;
10. Obvious blood coughing or daily hemoptysis of 2.5ml or above within 2 months beforeenrollment;
11. Subjects with any medical conditions that may increase the risk of gastrointestinalbleeding or gastrointestinal perforation, such as active gastrointestinal ulcers,known luminal metastases, inflammatory bowel disease, and a history of abdominalfistula, gastrointestinal perforation, or abdominal abscess within 28 days prior tostudy initiation;
12. Factors that significantly affect oral drug absorption, such as inability to swallow,chronic diarrhea and intestinal obstruction, including but not limited to a history ofstomach or small intestine resection, and malabsorption syndrome;
13. Subjects who have had any of the following cardiovascular diseases in the past sixmonths: Stroke (CVA) or transient cerebral ischemia (TIA), arrhythmia (including QTcinterval ≥450 ms for men and 470 ms for women), angina, coronary angiogenesis or heartstents, pulmonary embolism, Patients with untreated or anticoagulant therapy for lessthan 6 weeks with deep vein thrombosis, arterial thrombosis, Grade III or IV heartfailure as defined by the New York Heart Association's functional grading system, andclinically significant pericardial disease in patients with left ventricular ejectionfraction (LVEF) < 50% indicated by cardiac color ultrasound, Or electrocardiogramsuggests acute ischemia or abnormal conduction system;
14. Patients with active viral hepatitis B or hepatitis C, or active infections requiringantimicrobial treatment (e.g. antibiotics, antiviral drugs, antifungal drugs); 15.4weeks of participation in other antitumor clinical trials (non-immunotherapeutic;
15. Hypothyroidism patients: TSH>4.2mlU/L; 17.7 days of treatment with a potent CYP3A4inhibitor, or 12 days prior to study entry. Drugs with substrates for CYP3A4, CYP2D6, orCYP2C8 should be avoided; 18.4 weeks use of drugs that may lead to prolonged QT intervaland tip torsion; 19. Open wounds, sores or fractures; 20.4 weeks of surgery; 21. Serouseffusion (including pleural effusion, ascites, pericardial effusion) with clinical symptomsthat require surgical treatment; 22. Known hereditary or acquired bleeding and thrombotictendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hyperplenism,etc.); 23. Lactation period; 24. Hiv-positive patients; 25. Those who have a history ofpsychotropic substance abuse and cannot abstain or have mental disorders; 26. Any conditionthat the investigator considers to be prejudicial to the subject or to the subject'sinability to meet or perform the study requirements exists.