Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Kidney Neoplasms

Ureteral Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Ureteral Diseases

Quality of Life

Transitional Cell Carcinoma

Transitional Cell Cancer of the Renal Pelvis and Ureter

Patients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery

Removal of cancer mass by urether and kidney complete resection.

Nephroureterectomy

Francesco Montorsi, MD.

Francesco Fiorio, MSC

Francesco Montorsi, MD

Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery

Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.

Translational Cancer Observational Protocol

2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery

Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases. Data will be collected in a dedicated internal database by means of medical records obtained during the patients' stay in the hospital and during follow up visits. The data collected includes anamnesis, data regarding surgery, laboratory exam and imaging exams.

IRCCS San Raffaele

Professor

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Renal Insufficiency

Solitary Kidney

Congenital Abnormalities

Urogenital Abnormalities

Pathological Conditions, Anatomical

All Drugs and Chemicals

Disitamab vedotin

DV, 2.0 mg/kg, intravenously administered every 2 weeks; toripalimab, 3.0mg/kg, intravenously administered every 2 weeks;

2.0 mg/kg, intravenously administered every 2 weeks

3.0mg/kg, intravenously administered every 2 weeks

Toripalimab

Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy.

Laser surgery

Dingwei Ye, Doctor

Hailiang Zhang, Doctor

dingwei ye

Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment.

DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC

A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple Upper Urinary Tract Urothelial Carcinoma

Defined as the time to systemic relapse or death.

Defined as the time to systemic progression or death.

Defined by time from day of first treatment to RNU.

Defined by time from day of first treatment to death due to a specific disease, reflecting the clinical benefit of a specific disease.

Defined by time from day of first treatment to death.

Fudan University

Principal Investigator

Antineoplastic Agents

Nivolumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Nivolumab 360mg intravenous adminstration every 3 weeks

If you meet all the conditions to participate in the trial, you will receive the following treatments: Your physician will give you 360 mg of Nivolumab as an intravenous infusion every 3 weeks for about 30 minutes. For safety reasons, we recommend that you stay in the hospital for 60 minutes after the initial infusion of nivolumab. There will be a total of 3 cycles of Nivolumab treatments during the study period. You will need to return every 3 weeks. Each return will collect about 50 ml (10 tsp) of blood samples, depending on local standards.

Nivolumab 100 MG in 10 ML Injection

Yu-Li Su, MD

Chien-Ya Lin, RPN

The aim of this study is to explore efficacy and safety of neoadjuvant nivolumab for non-metastatic upper tract urothelial carcinoma (UTUC), and explore the potential predictive biomarkers of immunotherapy.

Upper urinary tract urothelial carcinoma (UTUC) is a malignant tumor originated from the epithelium of upper urinary tract (renal pelvis and ureter). The standard treatment of UTUC is radical nephroureterectomy with ipsilateral bladder cuff excision. For locally advanced disease, neoadjuvant chemotherapy or adjuvant chemotherapy with radiotherapy is also a considerable treatment. In general, patients with UTUC are often diagnosed in a late stage with a poor survival.

Nowadays, immune checkpoint inhibitor (ICI) emerged huge success in treatment of various type of cancers, including metastatic urothelial carcinoma. Several anti-PD1 or PD-L1 agents demonstrated an exciting response for metastatic urothelial carcinoma. The encouraging success makes clinical trials moving forward to neoadjuvant setting. In the PURE-01 study, patients with muscle-invasive bladder cancer received 3 cycles of neoadjuvant pembrolizumab achieving 39.5% pathological complete response (pCR). It brought a brand-new hope for organ-preservation treatment strategy. So far, neoadjuvant ICI has not been tested in patients with UTUC, irrespective for treatment efficacy or safety analysis. More importantly, there is still lack of reliable biomarkers to predict treatment response of ICI, which definitely an unmet medical need in clinical practice.

Therefore, the investigators proposed a phase II, open-label study of neoadjuvant nivolumab in locally advanced UTUC. Investigators believe that neoadjuvant nivolumab will achieve at least similar pCR rate compared with neoadjuvant pembrolizumab in UCB patients. Furthermore, investigators will conduct a comprehensive exploratory genomic analysis to identify the potential candidate biomarkers to predict the response of nivolumab.

Neoadjuvant Nivolumab for Upper Tract Urothelial Carcinoma

The NEVOLUTION Study: An Open Label, Single-arm, Phase II Study of Neoadjuvant Nivolumab in Locally Advanced Upper Tract Urothelial Carcinoma

determined by Clavien-Dindo classification

Milestone time points analysis of DFS6, DFS12, DFS 18 and median PFS by investigator assessment per RECIST 1.1

Milestone time points analysis of OS6, OS12, OS18 and median OS by investigator assessment per RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Translational Cancer Observational Protocol	NCT06169436	Upper Urinary T...	Nephroureterect...	18 Years -	IRCCS San Raffaele
DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC	NCT06354231	Renal Insuffici... Upper Urinary T... Solitary Kidney	DV Toripalimab Laser surgery	18 Years -	Fudan University
Translational Cancer Observational Protocol	NCT06169436	Upper Urinary T...	Nephroureterect...	18 Years -	IRCCS San Raffaele
Neoadjuvant Nivolumab for Upper Tract Urothelial Carcinoma	NCT05160285	Upper Urinary T...	Nivolumab 100 M...	20 Years - 85 Years	Chang Gung Memorial Hospital

Spots Global Cancer Trial Database for upper urinary tract urothelial carcinoma