About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational
Other interventionThis is a prospective observational study with observation only and no intervention
Treatment groups
Trial outcomes
Primary outcomes
Two-year events-free survival rate
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
defined as time from initiation for protocol therapy to death.
Metastasis free surviva
metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death
Other outcomes
Incidence of Treatment-Emergent Adverse Events
The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 5.0..
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
West China Hospital
Collaborator
Ruijin Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital of University of Science and Technology of China
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator