Study on MRD Prediction of Efficacy of Toripalimab in the Treatment of High-risk Recurrent Renal Carcinoma

The study population is high-risk recurrent renal cell carcinoma patients who have undergone radical nephrectomy and meet the criteria of ECOG Score 0-1, no residual tumor on imaging. The study subjects will undergo MRD testing about 3 weeks after surgery, and the drug will be started within 4 weeks of surgery. Imaging (CT, MRI) will be performed from the first dose of Toripalimab, every 12 weeks, and DFS will be evaluated. Survival will be recorded every 3 months. The study aims to investigate the predictive value of MRD technology for DFS and OS in these patients after surgery and provide reference for distinguishing patients who need adjuvant immunotherapy.

• There must be a histological diagnosis of renal cell carcinoma, with or without sarcomatoid features of clear cell components.
• On the day of signing the informed consent form, both males and females must be at least 18 years old.
• The participants provide written informed consent for the trial before enrollment.
• Have high risk or M1 NED renal cell carcinoma as defined by the following pathological tumor-node-metastasis and Fuhrman grading status.

• High risk RCC

• pT4, Any Gr. N0, M0
• pT Any stage, Any Gr., N+, M0
• M1 NED RCC (participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at the time of nephrectomy)
• No previous systemic treatment for advanced RCC (except nephrectomy or pyelectomy) has been performed.
• Radical nephrectomy (and complete resection of metastatic lesions in M1 NED participants) was performed with a negative surgical margin.
• It must be evaluated by the investigator as tumor-free and verified by imaging such as CT or MRI. No suspicious brain metastases.
• Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Non-surgical sterilization or female participants of childbearing potential who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of non-surgical sterilization or childbearing age within 7 days prior to study enrollment; And must be non-lactation period; Non-surgical sterilization or male patients of childbearing age who consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period.
• Vital organ function meets the following requirements (excluding use of any blood components and cell growth factors within 14 days) : normal bone marrow reserve function; Absolute neutrophil count (ANC)≥1500/µL, Platelets≥100 000/µL, Hemoglobin ≥5.6 mmol/L (9g/dL); Normal renal function or serum creatinine ≤1.5 mg/d and/or creatinine clearance ≥30 mL/min for participants with creatinine levels >1.5×institutional ULN; Normal liver function or Total bilirubin ≤1.5xULN, or direct bilirubin≤ULN for participants with total bilirubin levels >1.5×ULN; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.