Anlotinib Maintenance Treatment for Advanced Soft Tissue Sarcoma

Inclusion Criteria:

• Signed and dated informed consent form prior to patient entry;
• 18-70 years , regardless of gender；ECOG :0-2;Expected Survival Time: Over 3 months;
• Subjects with pathologically confirmed advanced synovial sarcoma, leiomyosarcoma,liposarcoma, angiosarcoma, etc. (except malignant peripheral nerve sheath tumor,undifferentiated sarcoma, rhabdomyosarcoma, chondrosarcoma, osteosarcoma, dermato-fibrosarcoma protuberans, gastrointestinal stromal tumor, ewing's sarcoma/primitiveneuroectodermal tumor, inflammatory myofibroblastic tumor, and malignantmesothelioma);
• Evaluable disease by imaging or physical exam or measurable disease defined as atleast one lesion that can be accurately measured according to RECIST version 1.1.
• PR/SD patients after ≥4 cycles anthracyclines treatment .
• Main organs function is normal.(normal main organs function as defined below:Hemoglobin (Hb) ≥ 80g / L, Neutrophils (ANC) ≥ 1.5 × 109 / L, Platelet count (PLT) ≥ 80 × 109 / L, Serum creatinine (Cr) ≤ 1.5 × normal upper limit (ULN) or creatinineclearance (CCr) ≥ 60ml / min, Blood urea nitrogen (BUN) ≤ 2.5 × normal upper limit (ULN); Total bilirubin (TB) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) and alanineaminotransferase (ALT) ≤ 2.5 × ULN; If accompanied by liver metastases, ALT and AST ≤ 5 × ULN Albumin (ALB) ≥ 25 g/L. Doppler ultrasound assessment: left ventricularejection fraction (LVEF) ≥ normal low limit (50%).)
• The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research andwithin another 6 months after it; who are not in the lactation period and examined asnegative in blood serum test or urine pregnancy test within 7 days before theresearch; The man patients who must agree to take contraceptive methods during theresearch and within another 6 months after it.

Exclusion Criteria:

• Prior treatment with anlotinib.
• A history of other malignancy ≤ 5 years previous.
• Systemic anti-tumor therapy, including cytotoxic therapy, signal transductioninhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment orduring the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior toenrollment.
• Unmitigated toxic reactions above grade 1 of CTC AE due to any previous treatment,excluding alopecia.
• Symptoms that affect oral medication and can not be controlled through propertreatment. (such as inability to swallow, chronic diarrhoea and intestinalobstruction, etc.)
• With pleural effusion or ascites, cause respiratory syndrome. (> CTC AE grade 2dyspnea [grade 2 dyspnea refers to shortness of breath during a small amount ofactivity; affecting instrumental activities of daily life])
• Symptoms of brain metastases cannot be controlled and treated within less than 2months.
• Thyroid dysfunction after best support treatment.
• With severe and failed to controlled diseases. (including:1)Uncontrollablehypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg,despite optimal drug treatment).2)Arrhythmias with grade II and above myocardialischemia or myocardial infarction, poor control (including corrected QT interval(QTc)men ≥ 450 ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York HeartAssociation ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose > 10mmol / L).4)Active or uncontrolled serious infection (≥ Common Terminology Criteria forAdverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B orhepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL;hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), oractive infection requiring antimicrobial treatment (eg Treated with antibacterialdrugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routineindicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;7)Patientswith seizures and need treatment.)
• Accepted surgical treatment, incision biopsy or significant traumatic injury within 28days before grouping.
• The investigator judged that during the follow-up study, the tumor is very likely toinvade the important blood vessels and cause fatal hemorrhage, or the formation oftumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins,superior vena cava)
• Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergonemajor surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodeswhich the degree is bigger than CTCAE 3 grade within 4 weeks prior to enrollment.
• Arteriovenous thrombosis events occurred within 6 months.
• History of psychotropic substance abuse who are unable to quit or have a mentaldisorder.
• Participated in other anti-tumor clinical trials within 4 weeks.
• The investigator believes that there are any conditions that may damage the subject orresult in the subject not being able to meet or perform the research request.