A Phase 3 interventional study of Axitinib plus Toripalimab and nephrectomy in Renal Cell Carcinoma and Neoadjuvant, sponsored by ZHOU FANGJIAN. Recruiting at 8 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by ZHOU FANGJIAN · Phase 3, Interventional, and Treatment
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.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's planned enrollment of 298 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →This is the only study on the registry with ZHOU FANGJIAN as lead sponsor.
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Cardiac function: Cardiac function class 0-2; Blood routine test: WBC≥3.5×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, PLT≥75.0×10\^9/L, HGB≥80g/L; Liver function: Total bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; Renal function: GFR ≥ 45 ml/min.
Exclusion Criteria:
Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy
Drug: Axitinib plus Toripalimab · Procedure: nephrectomy
The control group will be given nephrectomy alone.
Procedure: nephrectomy
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.
Also known as: nephrectomy
nephrectomy
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
Plan to share: No
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