Radical Nephrectomy With or Without Template Lymph Node Removal in High-Risk Kidney Cancer Patients to Improve Survival and Safety

What this Trial Is About

Researchers are investigating whether a more extensive lymph node removal surgery called Template Lymph Node Dissection can help patients with high-risk kidney cancer live longer and avoid cancer recurrence compared to removing only the visibly enlarged lymph nodes. This study focuses on patients with advanced kidney cancer features and aims to compare survival rates and safety between the two surgical approaches. It also explores the role of lymph node removal alongside newer immunotherapy treatments using a well-defined patient group. Participants will be randomly assigned to one of two surgery groups. One group will have their kidney removed along with a standardized set of lymph nodes based on tumor location template lymph node dissection. The other group will have kidney removal plus selective removal of only enlarged lymph nodes larger than 1 cm detected by imaging or during surgery. Surgery may be performed using open, laparoscopic, or robotic methods. After surgery, some patients may receive a free cycle of immunotherapy toripalimab based on their choice. Participants will attend regular follow-up visits with imaging scans such as CT or MRI for up to five years to monitor for cancer return. They will be tracked for survival outcomes for up to ten years. Researchers will assess disease-free survival, overall survival, cancer-specific survival, surgical complications, and lymph node involvement. Biomarker and imaging analyses will also be conducted to better predict lymph node metastasis and patient prognosis.

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