Neoadjuvant Therapy, Upper Urinary Tract Urothelial Carcinoma, Urothelial Carcinoma Ureter
Conditions
Brief 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.
Interventions
DRUGNeoadjuvant 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.
Sponsors
Changhai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy Safety and Tolerability | During chemotherapy and post-surgery follow-up | Incidence, severity, and clinical management of treatment-related adverse events (TRAEs) according to CTCAE v5.0. |
| Overall Survival (OS) | 24 months after surgery | Time from surgery to death from any cause. |
| Cancer-Specific Survival (CSS) | 24 months after surgery | Time from surgery to death due to UTUC. |
| Recurrence-Free Survival (RFS) | 24 months after surgery | Time from surgery to first recurrence of UTUC. |
Countries
China
Outcome results
None listed