soft tissue sarcoma
Conditions
Interventions
treatment group:Amroitinib hydrochloride
Sponsors
Beijing Jishuitan Hospital; Xijing Hospital, Military Medical University of The Air Force
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 75 years; 2. Histologically or cytologically confirmed soft tissue sarcoma patients with high grade, difficult surgical resection, moderate sensitivity to chemotherapy and above; 3. No previous anthracycline-based or anti-angiogenesis targeted therapy; 4. Measurable lesions according to RECIST version 1.1; 5. ECOG performance status 0-2, and the estimated survival should be more than 6 months. 6. Recovery from previous treatment according to NCI-CTCAE (version 4.0), all side effects (except hair loss) were reduced to grade 1 or below; 7. Normal function of the main organs: Hemoglobin (Hb) > 95g/L, Neutrophils (ANC) > 1.5 *10^9/L, Platelet count (PLT) > 80 *10^9/L. Serum creatinine (Cr) = 1.5 * normal upper limit (ULN), blood urea nitrogen (BUN) = 2.5 * normal upper limit (ULN); Total bilirubin (TB) = 1.5ULN; Glutamic-oxaloacetic transaminase (AST) and alanine-glutamic transaminase (ALT) were less than 2.5 *ULN. Albumin (ALB) > 35 g/L Prothrombin time (PT) and partial prothrombin time (PTT) = 1.2 *ULN Left ventricular ejection fraction (>50%) Blood pressure was controlled below 140/90 mmHg before admission. 8. Women of child-bearing age must have taken reliable contraceptive measures or carried out pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last medication. For men, consent must be given to appropriate contraceptive methods or surgical sterilization during the trial and within 8 weeks after the last administration of the drug. 9. Sign an informed consent (or a legal representative's signature) to prove that they understand the purpose of the study and the operation required by the research institute, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Previous exposure to antiangiogenic TKI drugs such as Anlotinib hydrochloride or other small molecules, or anti-angiogenic monoclonal antibodies (such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, apatinib, regfenil, etc.). 2. Systemic antineoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, or mitomycin C, was planned within the first four weeks of treatment or during the current study. Over-extended field radiotherapy (EF-RT) was performed in the first four weeks. 3. Other malignant tumors (except cutaneous squamous cell carcinoma) have developed in the past three years. 4. Imaging (CT or MRI) showed distant metastasis. 5. Imaging (CT or MRI) showed that the distance between the lesion and the great vessels was less than 5 mm, or there were tumors invading the local large vessels, or with thrombus formation of the great veins (iliac, inferior vena cava, pulmonary vein and superior vena cava). 6. Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment. 7. Uncontrollable hypertension (systolic blood pressure (>140 mmHg) or diastolic blood pressure (>90 mmHg), despite the best drug treatment; 8. Urinary routine indicated that urinary protein (++) or confirmed 24-hour urinary protein (> 1.0 g) and urinary protein/creatinine (> 1). 9. Uncontrolled complications, including, but not limited to, poorly controlled diabetes, persistent active infections, or psychiatric or social conditions that may affect subjects'compliance with the study; 10. Coagulation dysfunction (INR > 1.5 or PT > 1.2 ULN or PTT > 1.2 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation therapy; 11. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; 12. Within 2 months before admission, there was significant hemoptysis or hemoptysis of 2.5 ml or more per day. 13. Subjects with any disease that may increase the risk of gastrointestinal bleeding or perforation: active gastrointestinal ulcer, known intraluminal metastases, inflammatory bowel disease, history of abdominal fistula, gastrointestinal perforation or abdominal abscess within 28 days prior to the start of the study; 14. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, including but not limited to the history of gastric or small intestinal resection, malabsorption syndrome, etc. 15. 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 for males, 470 MS for females), angina pectoris, coronary angioplasty or stenting, pulmonary embolism, untreated or anticoagulant therapy for no time Deep venous thrombosis, arterial thrombosis, grade III or IV heart failure defined by the New York Heart Association (NYHA) functional grading system, color Doppler echocardiography showed that left ventricular ejection fraction (LVEF) < 50% was clinically significant pericardial disease, or electrocardiogram indicated acute ischemia or abnormal conduction system. 16. Patients with active hepatitis B or C or active infections need antimicrobial treatment (e.g. antimicrobial, antiviral and antifungal drugs); 17. Those who participated in other anti-tumor clinical trials (non-immunotherapy) within 4 weeks; 18. Patients with hypothyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Limb Preserved Rate;R0 Resection Rate;Local Recurrence Rate;Progression Free Survival;Progression Free Survival;Safety;Wound Complications; | — |
Countries
China
Contacts
Public ContactNiu Xiaohui
Beijing Jishuitan Hospital
Outcome results
None listed