Soft Tissue Sarcoma
Conditions
Interventions
Group 1:doxorubicin+ifosfamide
Group 2:Anlotinib hydrochloride, p.o.
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with high-grade soft tissue sarcoma that are relatively sensitive to chemotherapy after radical resection. Mainly include: synovial sarcoma, mucinous / round cell / pleomorphic liposarcoma, leiomyosarcoma, fibrosarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, epithelioid sarcoma, pleomorphic rhabdomyosarcoma, malignant peripheral Schwannoma, angiosarcoma, and connective tissue proliferative small round cell tumors. Except for the following: (1) Tumors that are highly sensitive to chemotherapy: Ewing's sarcoma, embryonic/Acinar rhabdomyosarcoma; (2) Tumors that are relatively insensitive to chemotherapy: dedifferentiated liposarcoma, clear cell sarcoma, alveolar soft tissue Sarcoma, extramedullary mucinous chondrosarcoma; (3) other tumors: gastrointestinal stromal tumors, invasive fibromatosis, sclerosing cutaneous fibrosarcoma, inflammatory myofibroblastic sarcoma. 2. Patients undergoing radical tumor resection. According to the AJCC soft tissue sarcoma staging system (eighth edition, 2016) TNM clinical staging, mainly including (1) patients with stage II have the following high risk factors: deep tumor location, tumor involvement of peripheral blood vessels, incomplete capsule or breakthrough compartment, FNCLCC Grade 3, local recurrence resection, etc.; (2) stage III patients; (3) stage IV patients: regional lymph node metastasis with regional lymph node dissection and no other distant metastasis. 3. postoperative pathological diagnosis of high-grade soft tissue sarcoma (according to FNCLCC soft tissue sarcoma grading system, pathological grade G2, G3), the diagnosis was completed by pathologists, pathological specimens (lumps or sections) confirmed by our center; 4. Male or female patients aged 18 years or older with an ECOG score of =90g/L (no blood transfusion within 14 days); ANC>=1.5×10^9/L; PLT>=80×10^9/L; 2) Biochemical examination: serum creatinine Cr >= upper limit of normal value (ULN); bilirubin BIL <=ULN; transaminase ALT, AST = 1.5 ULN (for patients with liver metastasis <=5 ULN); fasting triglyceride <=3.0mmol/L; fasting cholesterol <=7.75mmol/L; 6. Women of childbearing age are willing to use appropriate methods for contraception during the trial period and 8 weeks after the last administration of the test drug. If necessary, the early pregnancy test should be performed before the test; 7. Subjects voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received vascular endothelial growth inhibitor-like targeted drugs, such as pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, apatinib, ru Gefini and other drugs; 2. There were other history of malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Those who participated in other drug clinical trials within 4 weeks before the start of the study; 4. Patients who have previously used either rorotinib or chemotherapy; 5. Patients with a >1 grade toxic response to NCI-CTC AE grades due to prior treatment; 6, can not take oral medication or patients with chemotherapy contraindications; 7. Patients with distant metastases who cannot undergo radical surgery; 8. Patients with any severe and/or uncontrolled diseases, such as: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); (2) suffering from myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc >= 480ms) and >=grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled serious infection (>=CTC AE grade 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; (7) Poor diabetes control (fasting blood glucose (FBG)>10mmol/L); (8) Urine routine indicates that urine protein >=++, and confirmed 24-hour urine protein concentration > 1.0 g; (9) Those who have a history of abuse of psychotropic substances and who are unable to quit or have a history of mental disorders; 9. Long-term unhealed wounds or fractures in the chest and other areas; 10. Overactive/venous thrombosis occurred within 1 year prior to the start of the study, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 11. Pregnant women in childbearing age have a positive pregnancy test; 12. The accompanying disease or condition affects the safety of the patient during normal enrollment or study; 13. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival;1-year and 2-year disease-free survival rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local Recurrence Free Survival;Distant Metastasis Free Survival;Adverse reactions; | — |
Countries
China
Contacts
Public ContactZhenchao Yuan
Outcome results
None listed