soft tissue sarcoma
Conditions
Interventions
the group of treatment:Endostar combined with AI
Sponsors
Breast, Bone and Soft tissue Oncology Department, affiliated Tumor Hospital, Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patient aged 18 to 70 year male or females; 2. Patient with ECOG = 2; 3. Patient with histologically or cytologically confirmed soft tissue sarcomaincluding, Synovial sarcoma, Leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, Adipocytic, Tumors, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma; etexcept, Malignant peripheral nerve sheath tumor, Undifferentiated sarcoma, Rhabdomyosarcoma, chondrosarcoma, Osteosarcoma, Dermato- fibrosarcoma protuberans, GIST Primitive neuroectodermal tumor, Inflammatory myofibroblastic tumor, Malignant mesothelioma; 4. According to RECIST version 1.1 standard (appendix), the patient has at least one extracranial measurable lesions,(Spiral CT scans =10 mm, CT scanning layer is not more than 5 mm thick), it can be measured that lesions has not received radiotherapy; 5. Recurrent or metastatic STS, not using adriamycin and isophosphamide chemotherapy; If the drugs are used in adjuvant chemotherapy, they should be at least 6 months apart; 6. Expected lifetime acuity = 3 months; 7. Patients can have a history of brain/meningeal metastasis, but it must be before the start of the study after local treatment (surgery/radiotherapy), and clinically stable for at least eight weeks; 8. Normal function of major organs should meet the following criteria: (1) the blood routine examination must be in accordance with standard: 1) HB=90 g/L (14 days without blood transfusion); 2) ANC=1.5×10^9/L; 3) PLT=80×10^9/L; (2) the biochemical examination must be in accordance with the following criteria: 1) TBIL=1.5×ULN (higher than the normal limit); 2) ALT and AST=2.5×ULNif has liver metastasis ALT and AST=5×ULN; 3) Serum Cr=1×ULN the endogenous creatinine clearance>50 ml/min (Cockcroft-Gault formula); 9. Women of childbearing age are willing to using appropriate methods of contraception during the test and 8 weeks after having the last experimental drug, and should have a pregnancy check before test if necessary,the result should be negtive. 10. Subjects were willing to join in this study, sign the informed consent, good adherence, and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: patients who have previously used endostar; 1. being treated by vascular endothelial growth inhibitors, such as sunitinib, sorafenib, beacizumab, imatinib,apatinib, regorafenib; 2. The past five years has a history of other malignant tumors, but has been cured except skin basal cell carcinoma and cervical carcinoma in situ.? 3. 4 weeks prior to the start of the study involved in other drug clinical trial; 4. any unmitigated toxicity arising from any prior treatment that is more than a level 1 above CTC AE (4.0)except loss of hair 5. patients with any severe and/or uncontrolled disease including: (1) the blood pressure is not ideal (systolic pressure is greater than 150 mmHg, diastolic pressure is greater than 100 mmHg); (2) with level-i above myocardial ischemia and myocardial infarction, arrhythmia (including QTc 480 ms or higher) and level 2 or higher congestive heart failure (New York heart association (NYHA) classification); (3) serious infection that is either active or uncontrolled (greater than that of CTCAE 2); (4) liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; (5) kidney failure requires hemodialysis or peritoneal dialysis; (6) a history of immunodeficiency, including test positive for HIV or other acquired, congenital immunodeficiency disease, or a history of organ transplant; (7) diabetes control is not idea. (fasting glucose (FBG) (FBG) (>, 10mmol/L); (8) Routine urine prompt urinary protein>++and 24 hours urinary protein quantitative>1.0 g; (9) patients who have epilepsy and need treatment;? 6. imaging showed tumors invasion important blood vessels or researchers likely tumor important blood vessels and cause fatal hemorrhage patients during the follow-up; 7. A period of 6 months prior to the start of the study dynamic/enous thromboembolism event has occurred, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc; 8. according to the researchers' judgment, patients who have serious disease harm to the patient's safety or to completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Clinical benefit rate;Overall survival;Adverse reactions; | — |
Contacts
Public ContactWeimin Xie
Breast, Bone and Soft tissue Oncology Department, affiliated Tumor Hospital, Guangxi Medical University
Outcome results
None listed