Neoadjuvant Chemotherapy Before Surgery vs Surgery Alone for UTUC: A Randomized Trial

NCT07492225 · tracked via the Priya Life Science China tracker

Sponsor

Changhai Hospital

Phase

Phase 2

Started

2025-08-15

Last updated

2026-03-25

Condition(s) studied

Neoadjuvant TherapyUrothelial Carcinoma UreterUpper Urinary Tract Urothelial Carcinoma

Investigational drug(s) / intervention(s)

Neoadjuvant Gemcitabine + Cisplatin Chemotherapy

Neoadjuvant Gemcitabine + Cisplatin Chemotherapy: Patients in the experimental group will receive neoadjuvant chemotherapy with a combination of gemcitabine and cisplatin before undergoing surgery. The chemotherapy regimen consists of: Gemcitabine: 1000 mg/m², administered on Day 1 and Day 8 of each 21-day cycle. Cisplatin: 70 mg/m², administered on Day 2 of each 21-day cycle. This treatment will be repeated for 3 to 4 cycles. The goal of this chemotherapy is to shrink the tumor and improve the chances of a successful surgery. After completing the chemotherapy, patients will undergo radical nephroureterectomy (RNU), a surgery to remove the kidney and ureter affected by cancer, within 6 weeks (+/- 2 weeks) of the last chemotherapy cycle. This approach is designed to evaluate if chemotherapy before surgery can improve pathological response and long-term survival outcomes.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Histologically confirmed high-risk upper tract urothelial carcinoma (UTUC). 2. Clinically non-metastatic UTUC (N≤1, M0) based on imaging (CT/MRI). 3. Planned for radical nephroureterectomy (RNU). 4. ECOG performance status of 0 or 1. 5. Sufficient renal function (GFR ≥45 mL/min) and able to tolerate chemotherapy with cisplatin. 6. Age ≥18 years. 7. Informed consent signed. Exclusion Criteria: 1. Imaging shows ≥N2 disease or metastatic disease (M1). 2. History of invasive or lymph node-positive UTUC or invasive disease in the contralateral upper tract in the last 2 years. 3. Single kidney or contraindication to cisplatin. 4. Currently participating in other interventional clinical trials. 5. History of non-urothelial malignancies (except treated skin basal cell carcinoma or cervical carcinoma in situ). 6. Pregnant or breastfeeding women. 7. Any other medical condition deemed inappropriate by the treating physician.

Primary outcome measure(s)

Pathological Response Rate — 6 weeks after surgery
Proportion of patients with ypT1N0 or lower after surgery in the neoadjuvant chemotherapy + partial nephrectomy group compared to the direct partial nephrectomy group.

Trial sites (1)

Facility	City	Region	Status
Changhai Hospital	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07492225 on ClinicalTrials.gov ↗ ← All trials in China