A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RenJi Hospital
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Two-year events-free survival rate
Study Overview
Brief Summary
Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. The 5 year cancer specific survival is <50% for pT2/T3 and <10% for pT4. Radical nephroureterectomy is the standardized treatment for non-metastatic high risk UTUC. However, about half patients may suffer from impaired renal function after nephroureterectomy. On the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. The treatment for urothelial carcinoma has changed rapidly in the past few years. Immune checkpoint inhibitors and novel agents such as ADCs have shown promising therapeutic effect and were approved for patients with metastatic UTUC. Meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. This prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with UTUC with or without perioperative therapy in the real world.
Detailed Description
The patients that meet the Inclusion and Exclusion Criteria will enroll into this observational trial. The therapeutic schedule is purposed to spare the kidney of non-metastatic primary UTUC patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Histopathological confirmed upper tract urothelial carcinoma;
- •Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery;
- •Participants must be willing to attend the follow-up visits;
- •Sign informed consent.
Exclusion Criteria
- •Unable to undergo kidney-sparing surgery;
- •Life expectancy < 6 months;
- •Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.
Outcomes
Primary Outcomes
Two-year events-free survival rate
Time Frame: Up to 2 years
events-free survival defined as time from initiation of first protocol therapy until the first time to develop any local recurrence (local/bladder), distant metastases or any cause-related death.
Secondary Outcomes
- Overall survival(Up to 2 years)
- Metastasis free surviva(Up to 2 years)