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

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Axitinib

Criteria

Inclusion Criteria:

• Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0M0)

• 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