soft tissue Sarcoma
Conditions
Interventions
experimental group:Anlotinib combined with AI followed by Anlotinib sequential therapy
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, gender is not limited; 2. The pathological diagnosis of high-grade soft tissue sarcoma confirmed by histology or cytology, and the pathological type is moderately sensitive to chemotherapy and above; 3. Have not received anthracycline and anti-angiogenesis targeted drug therapy; 4. According to RECIST version 1.1, there are measurable lesions at baseline; 5. The ECOG performance status score (Appendix 2) is 0-2, and the expected survival time is greater than 6 months; 6. Recovery from previous treatment: All side effects (except alopecia) subsided to grade 1 or less according to NCI-CTCAE version 5.0 (Annex 5); 7. The function of major organs is normal, that is, the following criteria are met: hemoglobin (Hb) >= 95g/L, neutrophils (ANC) >= 1.5 x 10^9/L, platelet count (PLT) >= 80 x 10^9/L, serum Creatinine (Cr) = 35 g/L; prothrombin time (PT) and partial prothrombin time (PTT) = 50%; enrolled The previous blood pressure was controlled within 140/90 mmHg; 8. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and willing to use appropriate methods during the trial and 8 weeks after the last administration of the trial drug contraception. For males, consent to use of appropriate methods of contraception or surgical sterilization during the trial and within 8 weeks after the last dose of the trial drug; 9. Sign an informed consent form (or signed by a legal representative) to demonstrate that they understand the purpose of the study and the operations required by the study, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors that have occurred or are currently concurrently present within five years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) ) and T1 (tumor infiltrating basement membrane)]; 2. Imaging shows that the tumor has invaded around important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study; or patients with large veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava) tumor thrombus formation; 3. Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need to receive antiviral treatment; 4. Urine routine indicates urine protein >= ++, or confirmed 24-hour urine protein amount >= 1.0 g; 5. Uncontrolled comorbidities, including but not limited to: poorly controlled diabetes, persistent active infection, or mental illness or social conditions that may affect the subject's compliance with the study; 6. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; 7. Obvious hemoptysis, or 2.5ml or more of hemoptysis per day within 2 months before enrollment; 8. Subjects with any disease that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation: such as active peptic ulcer, known intraluminal metastases, inflammatory bowel disease, gastrointestinal bleeding within 28 days prior to the start of the study. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess; 9. Factors that significantly affect the absorption of oral drugs: such as inability to swallow, chronic diarrhea and intestinal obstruction, including but not limited to history of gastric or small bowel resection, malabsorption syndrome, etc.; 10. Subjects with any of the following cardiovascular diseases in the past six months: stroke (CVA) or transient ischemia (TIA), arrhythmia (including QTc interval >= 450 ms in men, Women >= 470 ms), angina, coronary angioplasty or stent, pulmonary embolism, deep vein thrombosis untreated or less than 6 weeks of anticoagulation, arterial thrombosis, as defined by the New York Heart Association (NYHA) functional classification system Patients with grade III or IV heart failure, patients with clinically significant pericardial disease with left ventricular ejection fraction (LVEF) <50% on echocardiography, or acute ischemia or abnormal active conduction system on electrocardiogram; 11. Patients with active viral hepatitis B or C, or those with active infections that require antimicrobial treatment (such as those requiring antibiotics, antiviral drugs, and antifungal drugs); 12. Those who have participated in other anti-tumor clinical trials within 4 weeks; 13. Received strong CYP3A4 inhibitor treatment within 7 days, or received strong CYP3A4 inducer treatment within 12 days before participating in the study. Drugs with CYP3A4, CYP2D6 or CYP2C8 substrates should be avoided; 14. Use of drugs that may cause QT interval prolongation and torsion de pointes in the electrocardiogram within 4 weeks; 15. Open wounds, ulcers or fractures; 16. Surgery within 4 weeks; 17. Serous effusion (including pleural effusion, ascites, and pericardial effusion) with clinical symptoms and requiring surgical treatment; 18. Known hereditary or acquired bleeding and thrombotic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease Control Rate;Adverse Reactions; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed