Bone and soft tissue sarcoma
Conditions
Interventions
One-armed clinical research,no group:Apatinib
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females, aged = 14 years; 2. Histologically confirmed advanced bone and soft tissue sarcoma; 3. Patients who have been treated with standard chemotherapy(eg.ADRDDPIFOMTX)and failed; 4. with measurable disease (tumor CT scan length diameter greater than 10 mm, lymph node lesions CT scan short diameter greater than 15 mm); 5. ECOG performance status 0-2; 6. Life expectancy estimated than 12 weeks; 7. Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: Hb =90g/L,ANC =1.5*10^9/L,PLT>100*10^9/L, ALB=30g/L, ALT and AST<2 times of upper limit of normal reference value, TBIL=1.5 times of upper limit of normal reference value, and sCr=1.5 times of upper limit of normal reference valueformula; 8. Patients without brain metastases; 9. Patients without mental disorder; 10. Normal thyroid function; 11. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. Patients who are diagnosed with hypertension which cant be reduced to normal range (systolic blood pressure> 150 mmHg / diastolic blood pressure> 100 mmHg), Patients who are diagnosed with I or higher level of myocardial ischemia or myocardial infarction, arrhythmia(including QTc interval= 440 ms; 3. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 4. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of alimentary tract hemorrhage in the past 6 months; 5. Patients with metastases to the central nervous system; 6. With psychotropic drug abuse history or mental disorder patients; 7. Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues; 8. The researchers don't think that is suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Quality of Life; | — |
Countries
China
Contacts
Public ContactXiaohui Niu
Beijing Jishuitan Hospital
Outcome results
None listed