NCT07321197Recruiting
Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC)
Template Lymph Node Dissection for Tumor Control in High-Risk Renal Cell Carcinoma: A Prospective, Open-Label, Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if a more thorough lymph node removal surgery, called "Template Lymph Node Dissection," can help prevent cancer from returning and help patients live longer, compared to removing only a few enlarged lymph nodes, in patients with high-risk kidney cancer. The main questions it aims to answer are: Do patients who receive template lymph node dissection live longer without their cancer returning (Disease-Free Survival)? Do patients who receive template lymph node dissection live longer overall (Overall Survival)? Is the more extensive lymph node surgery as safe as the limited surgery? Researchers will compare the Template Lymph Node Dissection group to the Limited Node Resection group to see the effects on cancer control and safety. Participants will: Be randomly assigned to one of the two surgical groups. Undergo surgery to remove their kidney and the assigned lymph nodes. Attend regular follow-up visits with imaging scans (like CT or MRI) for the first 5 years after surgery to monitor if the cancer returns. Be followed for their overall survival status for up to 10 years.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 21 Dec 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Tianjin Medical University Second Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT07321197
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 1 Sept 2025 to the primary completion date, 30 Sept 2028
- 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.
Prior treatment
- Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.
- Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).
- Use of immunosuppressive agents within 2 weeks prior to enrollment.
- Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior.
Other illness
- renal tumors or known hereditary RCC syndrome.
- Diagnosis of any other active malignancy within the past 5 years.
- Active autoimmune disease or history of autoimmune disease.
- Poorly controlled cardiac or clinical symptoms.
- Coagulopathy or bleeding tendency.
- Active gastrointestinal conditions with risk of bleeding or perforation.
- History of significant bleeding or thromboembolic events within specified timeframes.
- Active infection or unexplained fever \>38.5°C.
- History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function.
- Known immunodeficiency or active hepatitis.
- Known history of drug abuse or alcohol addiction.
- Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.
Other
- Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.
- Preoperative imaging indicates unresectable regional lymph nodes.
- Participation in another clinical trial within 1 month.
- Inability or unwillingness to bear the self-paid portion of examination and treatment costs.
Who the study is looking for
- Signed informed consent form.
- Age \> 18 years.
- Candidate for radical nephrectomy with or without lymph node dissection.
- High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node \>1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size \>= 10cm; OR hematuria and/or local symptoms.
- Measurable disease as per RECIST v1.1.
- ECOG performance status of 0 or 1.
- Adequate bone marrow, renal, and hepatic function.
- For women and men of childbearing potential, agreement to use effective contraception during the study period.
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 |
|---|---|---|---|
| Tianjin Medical University Second Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.