Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma

Inclusion Criteria:

1. Age 18-75 years.

2. ECOG Performance Status score of 0-1.

3. Histologically or cytologically confirmed diagnosis of high-grade soft tissuesarcoma (G2-G3), classified as moderately sensitive or higher to chemotherapy (ordetermined suitable for radiotherapy and chemotherapy by the investigator).Typically includes histological types such as synovial sarcoma, vascular sarcoma,adult fibrosarcoma, intramuscular chondrosarcoma, leiomyosarcoma, liposarcoma,undifferentiated pleomorphic sarcoma, hepatic undifferentiated embryonic sarcoma,and unclassified soft tissue sarcomas.

4. Clinical confirmation of soft tissue sarcoma suitable for surgical resection aftermultidisciplinary assessment.

5. Presence of at least one measurable lesion according to RECIST v1.1 assessmentcriteria and suitable for ≥40 Gy/f radiotherapy (or determined suitable forradiotherapy by the investigator).

6. Laboratory and other examinations:Hematology: Absolute neutrophil count ≥1500/μL,platelet count ≥100,000/μL. Pulmonary function: No respiratory difficulty at rest,no reduced exercise tolerance, resting pulse oximetry >94% in room air. Renal function (creatinine clearance or radioisotope GFR ≥70 mL/min/1.73 m² or serumcreatinine within normal limits according to age/gender). Liver function (totalbilirubin ≤1.5 × ULN, AST or ALT <2.5 × ULN). Cardiac function: Left ventricularejection fraction (LVEF) ≥50%.

7. Signed informed consent and good compliance.

8. Reproductive-age women must use reliable contraception or have a negative pregnancytest (serum or urine) within 7 days before enrollment and agree to use appropriatecontraception during the study and for 8 weeks after the last dose ofinvestigational drug.

Exclusion Criteria:

1. Active autoimmune disease or history of autoimmune disease.

2. Receipt of any form of anti-tumor treatment within 4 weeks prior to enrollment,including radiotherapy, chemotherapy, molecular targeted therapy (such asangiogenesis inhibitors like sunitinib, sorafenib, imatinib, famitinib,regorafenib), and immunotherapy (eligible if last anti-tumor drug was stopped ≥5half-lives before enrollment), or participation in another interventional clinicaltrial.

3. History of or current simultaneous malignancy within 3 years, excluding cured lungcancer, cervical carcinoma in situ, non-melanoma skin cancer, and superficialbladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumorinvades lamina propria)].

4. Unresectable sarcomas, including severe vascular, neural, or bone involvement, orcases where complete surgical resection is not safely feasible.

5. Factors affecting oral medication (such as dysphagia, severe chronic diarrhea, andintestinal obstruction, etc.).

6. History of bleeding, with any grade 3 or higher bleeding event as per CTCAE 4.0within 4 weeks before screening.

7. Uncontrolled diseases or past medical history, such as:

• NYHA Class ≥2 heart failure, unstable angina, myocardial infarction within thepast 12 months.

• Active infections requiring systemic treatment.

• Known HIV infection, syphilis history, psychiatric disorders (such as epilepsyand dementia), or substance abuse disorders.

• Thromboembolic events (including transient ischemic attacks, cerebralhemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolismwithin the past 6 months before enrollment.

8. According to NYHA standards, Class III-IV heart failure, or left ventricularejection fraction (LVEF) <50% on echocardiography.

9. Major surgery within 4 weeks prior to randomization or severe traumatic injury,fracture, or ulcer.

10. Long-standing unhealed wounds or fractures.

11. Pregnancy or lactation in women.

12. Known allergy to any investigational drug.

13. Investigator judgment that the subject has other factors that may lead to prematuretermination of the study, such as severe laboratory abnormalities, family or socialfactors affecting subject safety, or data and sample collection.