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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 298
- 试验地点
- 8
- 主要终点
- disease-free survival (DFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily agree to participate in this study and sign the informed consent form;
- •Males or females between 18 years old and 80 years old;
- •Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
- •CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
- •ECOG performance status: 0 or 1 point;
- •Sufficient heart, bone marrow, liver, and kidney functions:
- •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.
排除标准
- •With distant metastasis
- •Severe liver and renal dysfunction, combined with other serious diseases;
- •Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
- •Severe/unstable angina pectoris; uncontrolled hypertension;
- •Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
- •Ventricular arrhythmia requiring drug treatment.
研究组 & 干预措施
Neoadjuvant group
Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy
干预措施: nephrectomy (Procedure)
Control group
The control group will be given nephrectomy alone.
干预措施: nephrectomy (Procedure)
Neoadjuvant group
Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy
干预措施: Axitinib plus Toripalimab (Drug)
结局指标
主要结局
disease-free survival (DFS)
时间窗: 2 years
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.
次要结局
- objective response rate (ORR)(3 years)
- overall survival (OS)(3 years)
- adverse event management(3 years)
- The cancer-specific survival (CSS)(3 years)
- major pathological response (MPR)(3 years)
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University