Kidney-and-ureter removal with or without template lymph node removal for high-risk upper tract urothelial cancer
Clinical Efficacy and Safety of Radical Nephroureterectomy With Versus Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma: A Multicenter, Prospective, Randomized Controlled Clinical Trial
This trial will test whether adding a template lymph node removal to standard kidney-and-ureter surgery helps people with high-risk upper tract urothelial cancer live longer without the cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Second Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07321210 on ClinicalTrials.gov |
What this trial studies
This is a randomized trial comparing radical nephroureterectomy (RNU) with template lymph node dissection (TLND) versus RNU alone in patients with high-risk, non-metastatic upper tract urothelial carcinoma. Eligible patients are randomly assigned to one of the two surgical approaches, undergo the assigned operation, and are monitored for perioperative outcomes and complications. Follow-up visits with imaging and clinical checks occur regularly for five years, with the option for longer-term follow-up up to ten years to track disease-free and overall survival. Secondary measures include operative time, blood loss, length of hospital stay, and complication grades.
Who should consider this trial
Good fit: Adults (age ≥18) with unilateral, resectable, high-risk non-metastatic upper tract urothelial carcinoma scheduled for radical nephroureterectomy who meet high-risk features such as cT2 or higher, high-grade biopsy, significant hydronephrosis, tumor >2 cm, or suspicious regional nodes are ideal candidates.
Not a fit: Patients with metastatic disease, unresectable tumors, low-risk UTUC, or medical conditions that make lymph node dissection unsafe are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, adding a template lymph node dissection could improve disease-free and overall survival and help tailor further treatment for patients with high-risk UTUC.
How similar studies have performed: Retrospective and observational series have suggested possible diagnostic and therapeutic benefits from lymph node dissection in UTUC, but high-quality randomized evidence has been lacking until now.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Signed written informed consent form (ICF). Age \> 18 years at the time of ICF signing. Clinical diagnosis of unilateral Upper Tract Urothelial Carcinoma (UTUC) by imaging (enhanced CT or MRI) and/or ureteroscopic biopsy/urinary cytology, and scheduled to undergo Radical Nephroureterectomy (RNU). Clinical assessment indicating that the tumor and regional lymph nodes are completely resectable, with at least one of the following high-risk features: 1. Locally advanced: Preoperative imaging assessed as cT2 stage or higher (i.e., tumor invades muscularis propria or deeper). 2. High-grade: Preoperative ureteroscopic biopsy pathology confirmed as high-grade urothelial carcinoma (or with squamous differentiation/sarcomatoid differentiation). 3. Moderate or severe hydronephrosis: Ipsilateral moderate or severe hydronephrosis due to tumor obstruction. 4. Large tumor size: Imaging measures maximum tumor diameter \> 2 cm. 5. cN1: Imaging suggests regional lymph node short-axis diameter \> 1 cm, and the investigator judges it to be resectable. Presence of at least one measurable lesion according to RECIST v1.1 criteria. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate organ function meeting the following requirements (without use of any blood components or colony-stimulating factors within 14 days): Bone marrow function: Neutrophils ≥ 1,500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL (5.6 mmol/L). Renal function: Serum creatinine ≤ 1.5 mg/dL and/or Creatinine clearance ≥ 60 mL/min. Liver function: Total bilirubin ≤ 1.5 × ULN, AST \& ALT ≤ 1.5 × ULN. For women of childbearing potential (WOCBP): Must agree to use a highly effective medically approved contraceptive method during the treatment period and for 3 months after treatment ends. A negative serum or urine pregnancy test within 7 days before enrollment is required; must be non-lactating. For non-sterilized male patients: Must agree to use effective contraception with their partner during the treatment period and for 3 months after treatment ends. Subject voluntarily joins the study, has good compliance, and agrees to undergo safety and survival follow-up. Exclusion Criteria: Previous receipt of any anti-tumor therapy for UTUC, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy. History or concurrent presence of muscle-invasive bladder urothelial carcinoma. Preoperative imaging assesses regional lymph nodes as unresectable: lymph nodes fused into a massive conglomerate, or fully encasing the abdominal aorta/inferior vena cava/pelvic vessels preventing safe separation. Known bilateral UTUC or hereditary diseases that definitively increase the risk of contralateral upper tract tumors, such as Lynch Syndrome. Diagnosis of other active malignancies within the past 5 years (except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix which have been cured and show no recurrence within 5 years). Presence of any active autoimmune disease or history of autoimmune disease. Current use of immunosuppressants for immunosuppressive purposes, continued within 2 weeks prior to enrollment. Poorly controlled cardiac clinical symptoms or diseases. Coagulation abnormalities or bleeding tendency. Presence of specific active gastrointestinal conditions or uncontrolled tumor bleeding. History of significant bleeding, hemoptysis, or thromboembolic events within specified timeframes. Active infection or unexplained fever \> 38.5°C during screening or before the first dose. Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to surgery. History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, etc. Congenital or acquired immunodeficiency. Participation in another clinical study within 1 month prior to enrollment, or potential receipt of other systemic anti-tumor therapy during the study period. Known history of psychotropic drug abuse, alcohol abuse, or drug use. Inability or unwillingness to bear the out-of-pocket costs of examinations and treatments. Any other condition deemed by the investigator to make the subject unsuitable for participation.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Second Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Changyi Quan, MD — Tianjin Medical University Second Hospital
- Study coordinator: Shimiao Zhu, MD, PhD
- Email: zhushimiao@tmu.edu.cn
- Phone: +86 88328607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.