Spots Global Cancer Trial Database for Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
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Trial Identification
Brief Title: Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
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
Study ID: NCT05738694
Study Description
Brief Summary: The study included 246 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.
Detailed Description: Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. The study included 246 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Fangjian Zhou, Professor
Affiliation: Director of Dept. of Urology, Sun Yat-sen University Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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