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

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.

Study Overview

• Status: Recruiting
• Conditions: Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
• Intervention / Treatment: Other: Observational

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 Type: Observational
• Enrollment (Estimated): 106

Contacts and Locations

• Study Contact: Name: Jiwei Huang, Dr; Phone Number: 8613651682825; Email: jiweihuang@outlook.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200123
      • Recruiting
      • Shanghai Renji Hospital
      • Contact: Jiwei Huang, Dr; Phone Number: 8621-68383544; Email: jiweihuang@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy; 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.

Other: Observational; This is a prospective observational study with observation only and no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 5.0..	Up to 2 years

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Xiangya Hospital of Central South University; Shanghai Zhongshan Hospital; West China Hospital; First Affiliated Hospital Xi'an Jiaotong University; Ruijin Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Tianjin Medical University Second Hospital; The First Affiliated Hospital of University of Science and Technology of China; The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: upper tract urothelial carcinoma; kidney-sparing therapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: LY2023-081-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No