Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
- Conditions
- Renal Cell CarcinomaNeoadjuvant
- Interventions
- Procedure: nephrectomy
- Registration Number
- NCT05738694
- Lead Sponsor
- ZHOU FANGJIAN
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 246
- Males or females between 18 years old and 80 years old;
- Histopathologically confirmed clear cell carcinoma;
- Staged as T2G3-4 or T3-T4 or N1
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group nephrectomy The control group will be given nephrectomy alone. Neoadjuvant group nephrectomy Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy Neoadjuvant group Axitinib plus Toripalimab Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy
- Primary Outcome Measures
Name Time Method disease-free survival (DFS) 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.
- Secondary Outcome Measures
Name Time Method objective response rate (ORR) 3 years CR and PR rate as assessed by RECIST 1.1
overall survival (OS) 3 years overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause
adverse event management 3 years Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The cancer-specific survival (CSS) 3 years cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer.
major pathological response (MPR) 3 years MPR (≤10% viable malignant cells per local pathology assessment)
Trial Locations
- Locations (8)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Fudan University Cancer Hospital
🇨🇳Shanghai, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, China
West China Hospital
🇨🇳Sichuan, China
The First Affiliated Hospital of Zhengzhou Hospital
🇨🇳Zhengzhou, China
Peking University First Hospital
🇨🇳Beijing, China