Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Recruiting

• Conditions: Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

• Registration Number: NCT06204406
• Lead Sponsor: RenJi Hospital

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 Timeline

• Study Start: 2023-11-23
• Study First Submitted: 2023-11-26
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2028-07-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two-year events-free survival rate	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 Outcome Measures

Name	Time	Method
Overall survival	Up to 2 years	defined as time from initiation for protocol therapy to death.
Metastasis free surviva	Up to 2 years	metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death

Trial Locations

Locations (1)

Shanghai Renji Hospital; 🇨🇳 Shanghai, Shanghai, China