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Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Sponsor: ZHOU FANGJIAN
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.
Official title: A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
298
Start Date
2023-04-19
Completion Date
2027-12-31
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Axitinib plus Toripalimab
Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.
nephrectomy
nephrectomy
Locations (8)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Anhui Provincial Hospital
Hefei, China
Fudan University Cancer Hospital
Shanghai, China
West China Hospital
Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
The First Affiliated Hospital of Zhengzhou Hospital
Zhengzhou, China