Clinical trial · Observational
Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy
- description
- The enrolled patients were patients with limited-stage or locally advanced UTUC, who were classified into the following four categories according to the 2022 EAU guidelines as low-risk and high-risk: 1) low-risk patients who were willing to undergo kidney-sparing surgery directly; 2) High-risk patients, with solitary kidney, functional single kidney, bilateral tumors, and absolute kidney-sparing indications; 3) High-risk patients with renal insufficiency, or diseases that lead to renal insufficiency, have relative indications for kidney protection; 4) High-risk patients with good renal function, but a particularly strong willingness to preserve the kidney, willing to accept clinical studies and participate in kidney preservation.
- interventionNames
- Other: Observational
Primary outcomes (1)
- measure
- Two-year events-free survival rate
- timeFrame
- Up to 2 years
- description
- 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: 1. Histopathological confirmed upper tract urothelial carcinoma; 2. Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery; 3. Participants must be willing to attend the follow-up visits; 4. Sign informed consent. Exclusion Criteria: 1. Unable to undergo kidney-sparing surgery; 2. Life expectancy \< 6 months; 3. Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.
References
Publications (0)
Data not yet available