Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma (PLS-NEO-RCC)

Inclusion Criteria:

• Voluntary written informed consent.
• Age 18 years or older.
• ECOG performance status of 0 or 1.
• Life expectancy of at least 3 months.
• Preoperative biopsy confirming clear cell renal cell carcinoma or renal cell carcinoma with a predominant clear cell component.
• Willingness to undergo partial nephrectomy.
• A localized renal tumor for which partial nephrectomy is indicated but technically difficult: a 4-7 cm hilar tumor; a 4-7 cm tumor that is at least 75% endophytic; or a tumor larger than 7 cm.
• At least one measurable lesion suitable for repeated, accurate measurement.
• Adequate organ function: absolute neutrophil count ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; hemoglobin ≥90 g/L; total bilirubin ≤1.5 × upper limit of normal (ULN); ALT and AST ≤2.5 × ULN, or ≤5 × ULN for participants with liver metastases; albumin ≥28 g/L; INR and APTT ≤1.5 × ULN. No blood component transfusion or hematopoietic growth-factor support is permitted within 2 weeks before treatment.
• Willingness and ability to comply with study visits, treatment, laboratory assessments, and other study requirements.

Exclusion Criteria:

• Lymph node metastasis or metastatic renal cell carcinoma.
• Tumor encasement of the renal artery, tumor thrombus in the renal vein, or diffuse tumor growth without a clear boundary from normal renal parenchyma.
• Inability to tolerate general anesthesia according to the preoperative assessment.
• Severe cardiovascular or cerebrovascular disease, or uncontrolled hypertension or diabetes.
• Long-term immunosuppressive therapy after organ transplantation, or current use of immunosuppressive medication.
• Active infection or fever.
• T-cell lymphoma or multiple myeloma.
• Concurrent malignancy, current treatment for another benign or malignant tumor, or a history of another malignancy within the previous 6 months.
• Use of herbal medicines with an anticancer indication or systemic immunomodulatory agents, including thymosin, interferon, or interleukin, within 14 days before the first study treatment; local use to control pleural effusion is permitted.
• Active or potentially recurrent autoimmune disease, except vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis requiring only a stable dose of hormone replacement; or type 1 diabetes requiring only a stable dose of insulin.
• Concurrent enrollment in another interventional clinical study, except participation in its follow-up period; participation in a noninterventional observational study is permitted.
• Known psychiatric illness or a history of drug abuse, alcohol abuse, or illicit drug use.
• Pregnancy or breastfeeding.
• Any other disease, treatment, or laboratory abnormality that may confound the study results, prevent full participation, or make participation contrary to the participant's best interests.