Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma (NCT05895864) | Clinical Trial Compass
UnknownPhase 2
Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma
China34 participantsStarted 2023-06-07
Plain-language summary
This study is a open-label, multicenter, phase II study to evaluate the efficacy and safety of utidelone in the recurrent or metastatic urothelial carcinoma after prior chemotherapy.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Recurrent (unresectable) or metastatic urothelial carcinoma, Patients with primary urothelial carcinoma, mixed with other tissue components, failed or intolerant to standard treatment, and failed to receive neoadjuvant chemotherapy combined with immunotherapy for 12 months were allowed
. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
. The results of patient's laboratory biochemistry tests are as follows:
. Life expectancy ≥ 3 months
. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 3 months after the last day of treatment.
Exclusion criteria
. Pregnant or lactating women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: 24 months
Trial details
NCT IDNCT05895864
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. Suitable for radical means with a chance of cure
. Patients had received radiation therapy, TKI, or immune checkpoint inhibitor within 2 weeks after the initiation of the study
. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug
. 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;
. Known active infection with human immunodeficiency virus (HIV), hepatitis B, virus (HBV) or hepatitis C; virus (HCV)
. Prior allergies to castor oil
. 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