This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.

This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.

Inclusion Criteria:

• Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
• Schedule to undergo either partial or radical nephrectomy as part of treatment plan
• ECOG performance status of 0 or 1
• Adequate organ and marrow function defined by study-specified laboratory tests
• Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
• Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer

Exclusion Criteria:

• Patients who have received other systems for anti-tumor treatment
• Patients who have previously received targeted or immunotherapy
• Need for urgent or emergent nephrectomy to relieve symptoms
• Current use of immunosuppressive agents
• Pregnant or breastfeeding women
• History of autoimmune disease or syndrome