Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma

Exclusion Criteria

• •1. Pregnant or lactating women
• •2. Suitable for radical means with a chance of cure
• •3. Patients had received radiation therapy, TKI, or immune checkpoint inhibitor within 2 weeks after the initiation of the study
• •4. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug
• •5. Received an investigational agent, chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within 30 days prior to commencing study treatment, or have not recovered from all treatment-related toxicities to Common Toxicity Criteria (CTC) Grade less than or equal to 1, except for alopecia.CTCAE v.5.0 Grade greater than or equal to 2 peripheral neuropathy;
• •6. Known active infection with human immunodeficiency virus (HIV), hepatitis B, virus (HBV) or hepatitis C; virus (HCV)
• •7. Prior allergies to castor oil
• •8. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
• •9. Patients with mental disorders or poor compliance
• •10. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree II-III atrioventricular block, etc. The mean QTcF obtained from three 12-lead ECG examinations at rest was \>470ms. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular events occurred within 6 months before the first dose of dose. Clinically uncontrolled hypertension
• •11. Subjects with any other conditions were considered unfit for this study determined by the investigator