Soft tissue sarcoma, not otherwise specified
Conditions
Interventions
Experimental group:Utidelone + Anlotinib
Sponsors
Shandong First Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent before performing any trial-related procedures; 5 x the upper limit of normal (ULN); e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 60 ml/min; g) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) =18 years old, and =3 weeks for systemic therapy and >=2 weeks for radiotherapy or surgery. 6. At least one radiographic measurable lesion according to RECIST1.1 criteria; 7.ECOG score 0-1; 8. Expected survival time >3 months; 9. Good organ function if the following laboratory parameters were met: a) absolute neutrophil count (ANC) > 1.5x10^9 /L without granulocyte colony-stimulating factor administration for the past 14 days; 6 b) platelet count >=100×10^9 /L without blood transfusion in the past 14 days; c) hemoglobin >9g/dL in the past 14 days without blood transfusion or erythropoietin use; d) Total bilirubin =60ml/min; g) good coagulation function, defined as INR or PT <=1.5 times ULN; h) euthyroidism, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. i) myocardial enzymes within the normal range (simple laboratory abnormalities that were judged by the investigators to be clinically insignificant were also allowed); 10. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be performed within 3 days prior to receiving the first dose of study drug (day 1
Exclusion criteria
Exclusion criteria: 1. All soft tissue sarcomas except the following: highly chemotherapy-sensitive sarcomas: embryonal/alveolar rhabdomyosarcoma, Ewing's sarcoma; Chemotherapy-insensitive sarcomas: alveolar soft tissue sarcoma and extraskeletal myxoid chondrosarcoma, well-differentiated liposarcoma, clear cell sarcoma, inflammatory myofibroblastic tumor, malignant perivascular epithelioid cell tumor, gastrointestinal stromal tumor and desmoid fibromatosis; 2. Coagulation dysfunction; 3. Live vaccine administered less than 4 weeks before or possibly during the study administration; 4. Currently participating in an interventional clinical study treatment, or receiving another study drug or using a study device within 4 weeks before the first dose; 5. Had undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the study or anticipated need for major surgery during the study treatment. 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., CTCAE=2 chronic heart failure; c. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; d. A history of noninfectious pneumonia requiring glucocorticoid therapy within 1 year before the first dose or current clinically active interstitial lung disease; e. Active pulmonary tuberculosis; f. the presence of active or uncontrolled infection requiring systemic therapy; g. Presence of clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction; h. liver diseases such as cirrhosis, decompensated liver disease, acute and chronic active hepatitis; i. poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L); j. patients with a mental disorder who are unable to cooperate with treatment; k. known presence of symptomatic central nervous system metastases and/or carcinomatous meningitis; 10. Medical history or evidence of disease, treatment or laboratory abnormalities, or other conditions deemed by the investigator to be inappropriate for enrollment that may interfere with the results of the trial or preclude full participation in the study. 11. The patient had (A) poorly controlled hypertension; (B) central nervous system metastases; (C) persistent clinically significant toxicity due to previous cancer treatment; (D) active hepatitis B, hepatitis C or HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan;Xu Xin
Shandong First Medical University Affiliated Tumor Hospital (Shandong Provincial Tumor Prevention and Control Research Institute, Shandong Provincial Tumor Hospital)
Outcome results
None listed