soft tissue sarcoma
Conditions
Interventions
single arm group:Treatment was performed according to the combination regimen of cidabentamine and amlotinib
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participated in this study and signed the informed consent; 2. All advanced soft tissue sarcomas diagnosed by pathology, with at least one measurable lesion according to RECIST 1.1 criteria, mainly including synovial sarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberance, Ewing sarcoma/primary neuroectodermal tumor, desmoplastic circle Cellular tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma. Except for the following types: chondrosarcoma, osteosarcoma, malignant mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor; 3. Patients with refractory and advanced soft tissue sarcoma who have failed standard treatment; the expected survival time exceeds 3 months; 4. 18-70 years old, no gender restriction; ECOG PS score: 0-2 points; 5. Sufficient organ and bone marrow function, no severe hematopoietic dysfunction and cardiac, lung, liver, kidney, thyroid dysfunction and immune deficiency (within 14 days before the use of the study drug, no blood transfusion, granulocyte colony-stimulating factor or other relevant medical support); 6. Major organ function within 7 days prior to treatment, meeting the following criteria: (1) Blood routine examination standards (without blood transfusion within 14 days): hemoglobin (HB) >= 90 g/L (in patients with anemia caused by multiple tumor metastasis, hemoglobin >= 85 g/L); absolute neutrophil value (NEU) >=1.5x10^9/L; Platelet (PLT) >=75x10^9/L. (2) Blood biochemical tests meet the following criteria: total bilirubin (TBIL) =60ml/min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%); 7. Females 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 test within 7 days before study enrollment , and must be non-lactating patients; men should agree to patients who must use contraception during the study period and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously used Chidamide or other histone deacetylase inhibitors; 2. Patients who have previously received vascular endothelial growth inhibitor targeted drugs such as sunitinib, sorafenib, pazopanib, imatinib, famitinib, apatinib, and anlotinib; 3. Other malignant tumors that have occurred or are currently at the same time within five years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) ) and T1 (tumor infiltrating basement membrane)]; 4. 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]); 5. Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or using mitosis within 6 weeks before receiving the experimental drug), is planned within 4 weeks before enrollment or during the study drug period Mycin C). Extended-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 NCI CTC AE (5.0) grade 1 or higher due to any previous treatment, excluding alopecia; 7. Those with multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 8. Patients with brain metastases with symptoms or symptom control time less than 2 months; 9. 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; 10. Received major surgical treatment, incision biopsy or obvious traumatic injury within 4 weeks before enrollment; 11. 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; Those who have experienced arterial/venous thrombotic events within 12.6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 13. Patients with tumor thrombus; 14. Patients with a single tumor with a long diameter of >=20cm; 16. Those with active ulcer, intestinal perforation and intestinal obstruction; 17. Those who have a history of psychotropic substance abuse and canno
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival? overall survival?disease Control Rate; | — |
Countries
China
Contacts
Public ContactShen Zan
Shanghai Sixth People's Hospital
Outcome results
None listed