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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorRenJi Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    This is a prospective observational study with observation only and no intervention

Treatment groups

106 Participants
are divided into 1 treatment group
Group A: Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 2 years

Secondary outcomes

1

Overall survival

defined as time from initiation for protocol therapy to death.

Time frame
Up to 2 years
2

Metastasis free surviva

metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death

Time frame
Up to 2 years

Other outcomes

1

Incidence of Treatment-Emergent Adverse Events

The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 5.0..

Time frame
Up to 2 years

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