Bone malignancies
Conditions
Interventions
Group 1 :anlotinib
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
5 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 5-70 years old; 2. Pathologically confirmed bone tumors, including osteosarcoma, bone-derived undifferentiated pleomorphic sarcoma/bone-derived malignant fibrous histiocytoma; 3. Patients with recurrence/metastasis after systemic treatment at the front line, and patients who cannot undergo radical surgery, have at least one measurable lesion (according to RECIST1.1 standard); 4. All patients have failed chemotherapy (must contain anthracyclines) or cannot tolerate chemotherapy; 5. ECOG PS score: 0-1 points (PS score of amputee patients is 0-2 points), and the expected survival time is more than 3 months; 6. The main organ function meets the following criteria within 7 days before treatment: (1) Blood routine examination standard (without blood transfusion within 14 days): 1) Hemoglobin (HB) >= 90 g/L (for patients with anemia caused by multiple tumor metastasis, hemoglobin >= 85 g/L); 2) The absolute value of neutrophils (NEU) >= 1.5 x 10^9/L; 3) Platelets (PLT) >= 80 x 10^9/L; (2) Biochemical examination must meet the following standards: 1) Total bilirubin (TBIL) = 60 ml/min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%); 7. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days before study enrollment, And must be non-lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 8. Patients voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received targeted drug therapy of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, pazopanib, imatinib, famitinib, apatinib, Anro Drugs such as tinib and endostar; 2. Patients who have previously received gemcitabine combined with docetaxel are excluded. For patients who have used gemcitabine or docetaxel alone, they can be enrolled in the study 28 days after the completion of the last treatment; 3. Those who have received drainage of ascites and pleural effusion within 2 months after entering the group, and those with uncontrollable pericardial effusion, pleural effusion and ascites; 4. Other malignant tumors that have occurred or are currently suffering from other malignancies within 5 years, except for cured carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrates basement membrane)); 5. Planned systemic anti-tumor therapy within 4 weeks before enrollment or during the medication period of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or used mitotic therapy within 6 weeks before receiving experimental drug treatment) Mycin C). Had expanded-field radiotherapy (EF-RT) within 4 weeks before enrollment or limited-field radiotherapy for tumor lesions within 2 weeks before enrollment; 6. Unrelieved toxic reactions higher than CTCAE (5.0) grade 1 or higher due to any previous treatment, excluding hair loss; 7. People with multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 8. Patients with central nervous system metastasis; 9. Patients with any severe and/or uncontrolled diseases, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg and diastolic blood pressure >= 100 mmHg); (2) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc >= 480 ms) and >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled severe infection ( >= CTCAE grade 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) Those with a history of immunodeficiency, including those who are HIV positive or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; (7) Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); (8) Urine routine prompts urine protein >= ++, and confirmed 24-hour urine protein quantity > 1.0 g; (9) Patients who have epileptic seizures and need treatment; (10) Patients with abnormal thyroid function after optimal drug treatment; 10. Received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before enrollment; 11. Imaging studies show that the tumor has invaded important blood vessels or the researchers judged that the tumor is very likely to invade important blood vessels during the follow-up study and cause fatal massive hemorrhage; 12. Regardless of the severity, patients with any signs of bleeding constitution or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding events >= CTCAE grade 3, with unhealed wounds, ulcers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Objective Response Rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactShen Jingnan
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed