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.
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 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
298
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGPeking University First Hospital
Beijing, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, China
disease-free survival (DFS)
To evaluate the efficacy of the neoadjuvant combination of axitinib plus PD-1 in improving the 2-year disease-free survival (DFS) in RCC patients with high-risk for recurrent (T2G3-4 or T3-4, or N1). Disease-free survival (DFS) is defined as time from registration to disease progression or death.
Time frame: 2 years
The cancer-specific survival (CSS)
cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer.
Time frame: 3 years
overall survival (OS)
overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause
Time frame: 3 years
objective response rate (ORR)
CR and PR rate as assessed by RECIST 1.1
Time frame: 3 years
major pathological response (MPR)
MPR (≤10% viable malignant cells per local pathology assessment)
Time frame: 3 years
adverse event management
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 years
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Anhui Provincial Hospital
Hefei, China
RECRUITINGFudan University Cancer Hospital
Shanghai, China
RECRUITINGWest China Hospital
Sichuan, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou Hospital
Zhengzhou, China
RECRUITING