Soft-Tissue Sarcoma
Conditions
Interventions
Utidelone:Utidelone treatment
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients with unresectable locally advanced or metastatic soft tissue sarcoma; 2.Age =60 years; 3.Patients with Ewing's sarcoma or non-pleomorphic rhabdomyosarcoma have progressed after receiving at least two systemic treatment regimens, and patients with other soft tissue sarcoma have progressed on both anthracycline-based chemotherapy and anti-angiogenic TKI drugs; 4.Having at least one measurable lesion according to RECIST 1.1; 5.An ECOG performance status score of 0-1; 6.Neutrophil count = 1500/µL, platelets count = 80000/µL, and hemoglobin = 9.0 g/dl; 7.International normalized ratio = 1.5 ×ULN; 8.Serum creatinine = 1.5 ×ULN; 9.ALT and AST = 2.5 ×ULN (ALT and AST = 5×ULN in patients with liver metastasis) and bilirubin = 1.5 ×ULN; 10.Echocardiographic evaluation: left ventricular ejection fraction (LVEF) = 55%; 11.Women of reproductive age must have negative HCG test results in serum or urine within 7 days before enrollment, and are willing to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug, or those have been surgically sterilized or menopausal. For men, they must agree to use appropriate methods of contraception during the trial period and within 3 months after the last administration of the trial drug, or those have been surgically sterilized; 12.Other toxicity related to previous anti-tumor treatment must be restored to = grade 1 (CTCAE V5.0), but patients with hair loss of any grade are allowed to enter the study; 13.Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Having other malignant tumors at the same time; 2.Having symptomatic brain metastasis; 3.The CTCAE 5.0 grade of peripheral neuropathy =2 ; 4.Having a history of grade 3 or above nervous system related adverse events caused by previous anti-microtubule drugs; 5.Having contraindication of corticosteroids treatment, such as corticosteroid allergy, gastroduodenal ulcer, active tuberculosis, glaucoma, etc; 6.Having active infection, such as HIV infection, hepatitis B virus DNA quantitation = 1 × 103 copies/ml or hepatitis C virus antibody positive, active tuberculosis, etc; 7.Lactating or pregnant women; 8.Having a history of major surgery or trauma within 28 days before the treatment of trial drug; 9.Severe cardiovascular and cerebrovascular diseases including myocardial ischemia or myocardial infarction = grade 2, poorly controlled arrhythmias (including QTc interval = 450 ms for men and = 470 ms for women); according to NYHA standard, grade III ~ IV cardiac dysfunction, or left ventricular ejection fraction (LVEF) < 55%; 10.Those who are allergic to the trial drug; 11.History of mental illness: schizophrenia, anxiety disorder, depression, bipolar disorder, and other mental diseases receiving treatment or intervention; 12.Other factors that researchers consider inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Overall Survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactJiang Yu
West China Hospital, Sichuan University
Outcome results
None listed