Alveolar Soft Part Sarcoma Clinical Trials

• Only when all the following criteria are met will the subjects be eligible for inclusion in this study:

‣ The subjects voluntarily join this study, sign the informed consent form, and have good compliance;

⁃ ≥14 years old (calculated from the date of signing the informed consent form);

⁃ Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 1;

⁃ Expected survival greater than 12 weeks;

⁃ Pathologically confirmed recurrent and/or metastatic or unresectable alveolar soft part sarcoma, without previous systemic treatment;

⁃ Confirmed to have at least one measurable lesion according to RECIST 1.1;

⁃ Laboratory tests meet the following standards:

• Hemoglobin (HGB) ≥ 90g/L;

∙ Absolute neutrophil count (NEUT) ≥ 1.5×109/L;

∙ Platelet count (PLT) ≥ 100×109/L.

∙ Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);

∙ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If there is liver metastasis, ALT and AST ≤ 5 ULN;

∙ Serum creatinine (CR) ≤ 1.5 ULN or creatinine clearance rate (CCR) ≥ 60ml/min;

∙ Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (if not receiving anticoagulant therapy);

∙ Thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, the subject can be included.

⁃ Women of childbearing age must agree to use effective contraceptive measures during the study and for 6 months after the study, and have a negative serum test within 7 days before study enrollment; men must agree to use effective contraceptive measures during the study and for 6 months after the study.