Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC)

Summary

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.

Eligibility

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.

Conditions2

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