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

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. Bilateral 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. Coag…