Refractory soft tissue sarcoma
Conditions
Interventions
Apatinib group:Medical and nursing education for patients with soft tissue sarcoma
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. male or female patients over 16 years old: 2. patients with histologically confirmed soft tissue sarcoma (all other histologic types excluded) (see Annex 1); 3. More than 3 previously treated with standard chemotherapy and second-line treatment failure. Treatment failure was defined as: (1) within 3 months of the treatment in the course of disease progression or last treatment after disease progression, have clear imaging or clinical progression evidence; (2) due to inability to tolerate chemotherapy adverse events out of the standard treatment of patients, according to the standard of the CTCAE 4.0, the intolerance of the blood studies seriously adverse events level required to reach over degree IV (thrombocytopenia for grade III or higher) or non hematologic adverse events severity level reached grade III or above, and researchers determine the subjects repeated the original treatment still can not be tolerated. 4. ECOG physical status score: 0~2 points (see Annex 2); 5. the expected survival time more than 3 months; 6. the main organ function is good, that is, the random 14 days before the relevant inspection indicators to meet the following requirements: (1) blood routine examination: 1) hemoglobin > 90 g/L (no blood transfusion within 14 days); 2) neutrophil count >1.5*10^9/L; 3) platelet count >100*10^9/L; (2)Biochemical examination: 1) total bilirubin is less than 1.5 * ULN (upper limit of the normal value); 2) serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) is less than 2*ULN; such as liver metastasis, ALT or AST is less than 5*ULN; Creatinine clearance rate was higher than 60 ml/min III. endogenous (Cockcroft-Gault formula); (3) Doppler echocardiography assessment of left ventricular ejection fraction (LVEF = 50%). 7. Subjects accept other treatment caused damage has been restored, which received a nitroso or mitomycin interval distance signed informed consent is more than or equal to 6 weeks; receive other cytotoxic drugs and radiotherapy or surgery is more than or equal to 4 weeks, and the wound has healed completely. 8. signed informed consent; 9. compliance is good, the family agreed to cooperate with the survival of follow-up.
Exclusion criteria
Exclusion criteria: in the past or at the same time with other malignant tumors, but has been cured of skin and basal cell carcinoma of the cervix and cervical carcinoma in situ; 2. Previously received VEGFR small molecule tyrosine kinase inhibitors (such as Fahmi for Nepal, sorafenib, sunitinib for Nepal, regorafenib) in the treatment of patients with. 3 weeks to participate in clinical trials of other drugs; 4 various factors that influence oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); There are 5 bleeding history screening within 4 weeks before any serious level reached CTCAE4.0 in 3 degrees or more bleeding events; 6 patients with a history of central nervous system metastasis or a history of central nervous system metastasis were known before screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days of randomization, excluding transfer of the central nervous system; . with high blood pressure and by single antihypertensive drug therapy can not get good control persons (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); with unstable angina pectoris history.; screening within three months before the newly diagnosed angina or screening of myocardial infarction events occurred within the first 6 months; arrhythmias (including QTcF: men is more than or equal to 450 ms, the female is more than or equal to 470 MS) need long-term use of anti arrhythmic drugs and New York Heart Association classification is more than or equal to grade II cardiac insufficiency; 8 urine routine urinary protein is more than + + and confirmed the 24 hour urinary protein quantitative >1.0 g; 9 long term non healing wounds or incomplete healing of fracture; 10 imaging studies have shown that tumors have been invaded by important blood vessels or by the researchers to judge patients who have a high potential for invasion of major blood vessels during treatment and cause fatal bleeding; 11. Coagulation dysfunction, with bleeding tendency (before randomization 14 days must meet: in the case without the use of anticoagulants INR within the normal range); use of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues in the treatment of patients; in prothrombin time international normalized ratio (INR) is less than or equal to 1.5 premise, allowing to prevent use of low-dose warfarin (1 mg oral, once daily) or low dose aspirin (daily amount of not more than 100 mg); 12. Prior to the screening within a year happened artery / vein thrombosis events, such as cerebral vascular accident (including transient ischemic attack), deep venous thrombosis (for pre chemotherapy vein indwelling tube causing venous thrombosis by the researchers judged to have been recovered except) and pulmonary embolism, etc.; 13. For female subjects: for sterilization, postmenopausal patients, or agree to within 6 months after the study during the period of treatment and the end of the treatment period using a medically acceptable contraceptive measures; in research into within 7 days of the former group serum or urine pregnancy tests must be negative, and must be in non lactating period. Male subjects: for sterilization, or agree to within 6 months after the study during the period of treatment and the end of the treatment period using a medically acceptable contraceptive measures, patients should be. 14 there was a previous thyroid dysfunction, eve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Countries
China
Contacts
Public ContactWang Xiuwen
Outcome results
None listed