NCT07492225Active, not recruitingPhase 2
Neoadjuvant Chemotherapy Before Surgery vs Surgery Alone for UTUC: A Randomized Trial
Comparative Efficacy of Neoadjuvant Chemotherapy Versus Immediate Nephroureterectomy in the Treatment of Localized Upper Tract Urothelial Carcinoma: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
This clinical trial aims to compare the effectiveness and safety of two treatment options for patients with high-risk upper tract urothelial carcinoma (UTUC). One group will receive neoadjuvant chemotherapy with gemcitabine and cisplatin followed by surgery (radical nephroureterectomy), while the other group will undergo surgery without chemotherapy. The primary goal is to assess the pathological response to treatment, focusing on how much the tumor shrinks before surgery. The trial will also evaluate the safety of the treatments, overall survival, and recurrence-free survival. This study will help determine whether adding chemotherapy before surgery improves outcomes for patients with high-risk UTUC.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 15 Aug 2025
- Primary completion date
- 15 Aug 2027
- Lead sponsor
- Changhai Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07492225
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 15 Aug 2025 to the primary completion date, 15 Aug 2027
- 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.
Other illness
- Imaging shows ≥N2 disease or metastatic disease (M1).
- History of invasive or lymph node-positive UTUC or invasive disease in the contralateral upper tract in the last 2 years.
- History of non-urothelial malignancies (except treated skin basal cell carcinoma or cervical carcinoma in situ).
- Any other medical condition deemed inappropriate by the treating physician.
Other
- Single kidney or contraindication to cisplatin.
- Currently participating in other interventional clinical trials.
- Pregnant or breastfeeding women.
Who the study is looking for
- Histologically confirmed high-risk upper tract urothelial carcinoma (UTUC).
- Clinically non-metastatic UTUC (N≤1, M0) based on imaging (CT/MRI).
- Planned for radical nephroureterectomy (RNU).
- ECOG performance status of 0 or 1.
- Sufficient renal function (GFR ≥45 mL/min) and able to tolerate chemotherapy with cisplatin.
- Age ≥18 years.
- Informed consent signed.
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 |
|---|---|---|---|
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.