Template lymph node surgery plus kidney removal vs kidney removal alone for high-risk kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized trial compares radical nephrectomy with template lymph node dissection to radical nephrectomy with limited node resection in adults with high-risk renal cell carcinoma. Participants are randomly assigned to receive either the broader template LND or the limited node removal during surgery, followed by regular imaging to monitor cancer status. Primary outcomes include overall survival and disease-free survival, with safety and postoperative complications tracked. The trial builds on mixed prior data and aims to clarify whether extensive nodal removal provides a meaningful oncologic benefit in this specific high-risk population. Eligible patients have high-risk features and adequate organ function, and participating centers include multiple institutions in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.
* Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).
* Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.
* Preoperative imaging indicates unresectable regional lymph nodes.
* 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.
* Use of immunosuppressive agents within 2 weeks prior to enrollment.
* 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.
* Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior.
* History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function.
* Known immunodeficiency or active hepatitis.
* Participation in another clinical trial within 1 month.
* Known history of drug abuse or alcohol addiction.
* Inability or unwillingness to bear the self-paid portion of examination and treatment costs.
* Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.