drugset / Trial / NCT05738694

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

NCT05738694

Phase 3 Recruiting 298 enrolled ZHOU FANGJIAN Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-04-19
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule 5 mg Oral
Subject Toripalimab Monoclonal antibody 240 mg

Indications