Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. The study included 298 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.

Inclusion criteria

• Voluntarily agree to participate in this study and sign the informed consent form;
• Males or females between 18 years old and 80 years old;
• Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
• CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
• ECOG performance status: 0 or 1 point;
• Sufficient heart, bone marrow, liver, and kidney functions:

Cardiac function: Cardiac function class 0-2; Blood routine test: WBC≥3.5×10^9/L, absolute neutrophil count ≥1.5×10^9/L, PLT≥75.0×10^9/L, HGB≥80g/L; Liver function: Total bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; Renal function: GFR ≥ 45 ml/min.

Exclusion criteria

• With distant metastasis
• Severe liver and renal dysfunction, combined with other serious diseases;
• Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
• Severe/unstable angina pectoris; uncontrolled hypertension;
• Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
• Ventricular arrhythmia requiring drug treatment.