NCT07504939Not yet recruiting
Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma
Evaluating a Kidney-sparing Strategy Combining Endoscopic Surgery, Adjuvant Radiotherapy, and HER2-targeted Antibody-Drug Conjugate in High-risk Upper Tract Urothelial Carcinoma: Study Protocol for a Prospective, Multicenter, Non-randomized Comparative Clinical Trial
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function. Endoscopic treatment can serve as a kidney-sparing approach for low-risk UTUC; however, in high-risk patients, the high rate of upper tract local recurrence after endoscopic treatment remains the primary failure pattern. This study aims to evaluate the efficacy and safety of radiotherapy-involved kidney-sparing treatment for UTUC. The main questions this study aims to answer are: Can this multimodal kidney-sparing strategy reduce local recurrence of UTUC compared with endoscopic treatment alone? Participants in the kidney-sparing group will: Undergo endoscopic surgery to remove the tumor; Receive systemic therapy with disitamab vedotin and toripalimab; Receive targeted radiotherapy after surgery. Participants will undergo regular follow-up visits, including imaging examinations and endoscopic evaluations, to monitor for recurrence or disease progression. The results of this study may help determine whether a multimodal kidney-sparing treatment strategy could become a safe and effective option for selected patients with high-risk UTUC.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 36 (estimated)
- First submitted
- 8 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Peking University First Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07504939
What you commit to
- Study type: Observational
- Planned participants: 36
- From 1 Apr 2026 to the primary completion date, 1 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Participants must meet all of the following criteria:
- Age 18 years or older Voluntary participation with written informed consent Pathology indicating upper tract urothelial carcinoma with HER2 at least 1+ expression Clinical stage cT1-T2N0M0 based on imaging evaluation Classified as high-risk upper tract urothelial carcinoma according to European Association of Urology (EAU) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate renal function with split renal function of the affected kidney ≥10 mL/min on renal dynamic scintigraphy Expected life expectancy greater than 24 months Ability and willingness to comply with study procedures and follow-up schedule Exclusion Criteria
- Participants will be excluded if any of the following conditions are present:
- Inability to tolerate or refusal of kidney-sparing treatment Evidence of advanced disease (≥T3), lymph node metastasis, or distant metastasis Synchronous bladder urothelial carcinoma or other urological malignancies Previous systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or antibody-drug conjugates Prior radiotherapy involving the urinary tract or retroperitoneal region Severe uncontrolled comorbidities such as cardiovascular, pulmonary, neurological, psychiatric, or systemic diseases Active severe infections requiring systemic antimicrobial therapy Known immune-related disorders requiring long-term immunosuppressive treatment Pregnancy or breastfeeding Known allergy to investigational drugs used in this study Concurrent participation in another therapeutic clinical trial Indeterminate postoperative pathological diagnosis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Departmeng of Urology, Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.