Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07321210

Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC): A Randomized Clinical Trial

Led by Tianjin Medical University Second Hospital · Updated on 2026-01-06

150

Participants Needed

1

Research Sites

347 weeks

Total Duration

On this page

Sponsors

T

Tianjin Medical University Second Hospital

Lead Sponsor

C

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if adding a template lymph node dissection (TLND) to the standard surgery for upper tract urothelial cancer (UTUC) can improve patient survival and prevent the cancer from recurrence. The main questions it aims to answer are: Do patients who receive standard surgery with LND live longer without their cancer returning? Is adding LND safe, and how does it affect surgery-related complications? Researchers will compare the group receiving standard surgery plus LND to the group receiving standard surgery alone to see if adding LND is more effective. Participants will: Be randomly assigned to one of the two surgical groups. Undergo their assigned surgery and recover in the hospital. Attend regular follow-up visits for checkups and scans for 5 years to monitor for cancer recurrence, with the possibility of long-term follow-up extending to 10 years.

CONDITIONS

Official Title

Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC): A Randomized Clinical Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form.
  • Age over 18 years at time of consent.
  • Clinical diagnosis of unilateral upper tract urothelial carcinoma by imaging or biopsy.
  • Scheduled for radical nephroureterectomy surgery.
  • Tumor and regional lymph nodes assessed as completely resectable.
  • Presence of at least one high-risk feature: locally advanced tumor (cT2 or higher), high-grade urothelial carcinoma, moderate or severe hydronephrosis, tumor size over 2 cm, or regional lymph nodes larger than 1 cm and resectable.
  • At least one measurable lesion by RECIST v1.1 criteria.
  • ECOG performance status of 0 or 1.
  • Adequate bone marrow, renal, and liver function.
  • For women of childbearing potential: use of effective contraception and negative pregnancy test.
  • For non-sterilized men: use of effective contraception.
  • Willingness to comply with study procedures and follow-up.
Not Eligible

You will not qualify if you...

  • Prior anti-tumor therapy for upper tract urothelial carcinoma.
  • History or current muscle-invasive bladder urothelial carcinoma.
  • Unresectable regional lymph nodes due to fusion or involvement of major vessels.
  • Known bilateral upper tract urothelial carcinoma or hereditary conditions like Lynch Syndrome.
  • Other active malignancies within past 5 years except certain cured skin or cervical cancers.
  • Active or history of autoimmune disease or recent use of immunosuppressants.
  • Poorly controlled heart conditions.
  • Coagulation or bleeding disorders.
  • Active gastrointestinal conditions or ongoing tumor bleeding.
  • Recent significant bleeding, hemoptysis, or thromboembolic events.
  • Active infection or unexplained fever above 38.5°C.
  • Recent abdominal fistula, gastrointestinal perforation, or abscess.
  • Lung conditions such as pulmonary fibrosis or severe impaired function.
  • Immunodeficiency or recent participation in another clinical trial.
  • History of psychotropic drug, alcohol, or drug abuse.
  • Inability or unwillingness to cover examination and treatment costs.
  • Any other condition deemed unsuitable by investigators.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, China, 300211

Actively Recruiting

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Research Team

S

Shimiao Zhu, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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