osteosarcoma
Conditions
Interventions
single arm:Apatinib or apatinib + chemotherapy
Sponsors
Xijing Hospital affiliated to The Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 12-65 years; 2. advanced osteosarcoma; 3. osteosarcoma first-line chemotherapy treatment failure; 4. the new adjuvant or adjuvant chemotherapy of osteosarcoma and progression of osteosarcoma in the first week after the end of the first line of chemotherapy in patients with disease progression, more than 6 months of disease progression need to obtain the consent of the subjects themselves or their legal representatives; 5. according to the RECIST version 1.1, baseline measurable lesions; 6. ECOG physical status score of 0-1, is expected to survive more than 3 months.
Exclusion criteria
Exclusion criteria: 1. hypertension after antihypertensive drug treatment can not to the normal range (>140 mmHg systolic blood pressure, diastolic blood pressure >90 mmHg), suffering from coronary heart disease, arrhythmia or grade II (including prolonged QTc interval, male female MS > 450, > 470 MS) and heart failure; 2. have a variety of factors affecting the absorption of oral drugs (such as swallowing, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. active bleeding, 30 days after major surgery; Special note: with the risk of gastrointestinal bleeding of patients can not into the group, including the following: (1) with active peptic ulcer lesions, and fecal occult blood (+ +); (2) within 3 months of melena and hematemesis history; (3) for fecal occult blood (+) to the stomach bronchoscopy, clear whether gastrointestinal organic diseases; 4. in the past 3 years with other malignant tumors. 5. coagulation dysfunction (INR>1.5 * ULN, APTT>1.5 * ULN), with bleeding tendency; 6. any allergic to any ingredient of this product; 7. patients with intracranial metastasis; 8. within the last 3 weeks after systemic cytotoxic therapy, radiation therapy, or any of the experimental drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR;OS;DCR;QLQ; | — |
Countries
China
Contacts
Public ContactHongmei Zhang
Xijing Hospital affiliated to The Fourth Military Medical University
Outcome results
None listed