Clinical trial · Observational
Neoadjuvant Radiotherapy for High-risk UTUC
Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion \[cT2 and above\], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma of the Renal Pelvis and Ureter | Renal Pelvis and Ureter Urothelial Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant drug therapy | Combination Product | — | UNRESOLVED |
| Neoadjuvant radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Neoadjuvant radiotherapy+radical surgery
- description
- Patients with high-risk UTUC without distant metastases (which can be accompanied by regional lymph node metastases) were selected to receive short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) after completion of biopsy and definitive pathological diagnosis, and to undergo radical surgery within 3 months from completion of the last radiotherapy session
- interventionNames
- Radiation: Neoadjuvant radiotherapy
- label
- Neoadjuvant radiotherapy and drug therapy+radical surgery
- description
- Patients with high-risk UTUC without distant metastases (which may be accompanied by regional lymph node metastases) were selected to receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing a biopsy and making a definitive pathological diagnosis, and to undergo a radical surgical procedure within 3 months from the end of the last radiotherapy session (full-length radical nephroureteral resection + cystocele sleeve resection ) treatment. Pharmacological treatment can be chemotherapy/immunotherapy/ADC treatment etc.
- interventionNames
- Radiation: Neoadjuvant radiotherapy
- Combination Product: Neoadjuvant drug therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: ·≥18 years old, no gender limits, diagnosed as high-risk UTUC without existing distant metastasis or other malignancies; * Completed pathological biopsy with a clear pathological diagnosis : including puncture biopsy, ureteroscopy and urine cytology, at least one of which is clearly diagnosed as uroepithelial carcinoma, which may include no more than 50% or more proportion of squamous, adenoid, sarcomatoid differentiation and other special differentiation types; * Have the willingness to undergo radical surgical treatment and perioperative adjuvant treatment, have good compliance, and be able to co-operate with the treatment and follow-up plan specified by the clinician; * Postoperative life expectancy of at least 6 months; ECOG score ≤ 2. Exclusion Criteria: * Distant metastases or other malignant neoplastic diseases combined with other malignant neoplasms in the same period had been detected at the time of surgery, or the present was a progression after palliative resection of previous epithelial carcinoma of the urothelium; * History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; * Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception; * The presence of active infections in those with pre-existing or coexisting haemorrhagic disorders * clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease); * Psychological, familial, and social factors leading to lack of informed consent.
References
Publications (0)
Data not yet available