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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT06204406

LY2023-081-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

106 participants in 1 patient group

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.

Treatment:

Other: Observational