Soft tissue Sarcoma
Conditions
Interventions
Experimental group:Eribulin plus anlotinib
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years; 2. The diagnosis of advanced soft tissue sarcoma by the center mainly includes synovial sarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, hyaline cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, protuberant cutaneous fibrosarcoma, Ewing's sarcoma/primary neuroectodermal tumor Small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma. But the following types are excluded: chondrosarcoma, osteosarcoma, malignant mesothelioma, alveolar soft tissue sarcoma, gastrointestinal stromal tumor; 3. The patient may have a history of brain/meningeal metastasis, but must undergo local treatment (surgery/radiotherapy) before the start of the study and be clinically stable for at least 8 weeks; 4. Patients with refractory and advanced soft tissue sarcoma who failed standard treatment; The expected survival period is more than 3 months; 5. According to the RECIST 1.1 standard, there is at least one measurable target lesion (= 10mm (CT scan thickness is not greater than 5mm), and the measurable lesion has not received radiotherapy; 6. ECOG physical condition score 0-1 or KPS score>70; 7. Appropriate bone marrow and organ function: WBC = 3.5 × 109/L, N greater than 1.5, PLT = 80 × 109/L, Hb = 10.0g/dL, serum Alb = 35g/L, serum creatinine = 1ULN, endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula), ALT = 2.5 ULN, AST = 2.5 ULN, if there is liver metastasis, ALT and AST = 5 × ULN Total serum bilirubin = 1.5 ULN, cardiac ultrasound: LVEF>60%. All laboratory test results should be within the above stable range, and there is no continuous supportive treatment in the past 2 weeks; 8. Be able to comply with the protocol during the study; 9. Subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with follow-up; 10. Women with fertility must have a negative pregnancy test in urine or serum within 7 days before enrollment, and must agree to take effective contraceptive measures during the study period and at least 2 months after the last administration; 11. The male who has not been sterilized must agree to take effective contraceptive measures during the study period and at least 2 months after the last administration.
Exclusion criteria
Exclusion criteria: 1.Patients who have accepted anlotinib or other angiogenisis inhibitors, such as pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, apatinib, regafenib, anlotinib etc; 2.Other malignant tumors have occurred within the past five years. The cured cervical carcinoma in situ, nonmelanoma skin cancer and superficial bladder tumors are permitted [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor-infiltrating basement membrane)]; 3.Accompanied by pleural effusion/ascites exceeding 800ml or respiratory syndrome caused by pleural effusion/ascites (according to NCI CTC AE (5.0) grading = grade 2 dyspnea. [Grade 2 dyspnea refers to shortness of breath during a small amount of activity ; affect instrumental activities of daily living]); 4.Systemic antitumor therapy was planned within 4 weeks before the enrollment or during this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or using mitomycin C within 6 weeks prior to treatment with the study drug). Field-expanded radiation therapy (EF-RT) was performed within 4 weeks prior to enrollment. Field-limited radiation therapy for tumor lesions was performed within 2 weeks prior to enrollment. 5.Unrelieved toxic reactions higher than NCI CTC AE (5.0) grade 1 or higher due to any previous treatment, excluding alopecia 6.Those with multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 7. Patients with brain metastases with symptoms or symptom control time less than 2 months; 8. Patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure = 150 mmHg, diastolic blood pressure =100 mmHg); patients with grade I or above myocardial ischemia or myocardial infarction, Arrhythmia (including QTc = 480ms) and = grade 2 congestive heart failure (New York Heart Association (NYHA) classification); active or uncontrolled serious infection ( = NCI CTC AE (5.0) grade 2 infection); Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral therapy; renal failure requiring hemodialysis or peritoneal dialysis; history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency Disease, or a history of organ transplantation; poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L); urine routine indicates urine protein = ++, and confirmed 24-hour urine protein quantitative > 1.0g; epileptic seizures and patients in need of treatment; 9. Received major surgical treatment, incision biopsy or obvious traumatic injury within 4 weeks before enrollment; 10. Regardless of the severity, patients with any signs of bleeding constitution or medical history; patients with any bleeding or bleeding events = CTCAE grade 3 within 4 weeks before assignment, with unhealed wounds, ulcers or fractures; 11. Those who have experienced arterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 12. Patients with tumor thrombus; 13. Patients with a single tumor with a long diameter of = 20cm; 14. Those with active ulcer, intestinal perforation and intestinal obstruction; 15. Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; 16. Patients with tumor invading important blood vessels. Investigators j
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease Control Rate;Adverse Reactions; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed