Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

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