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Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

RecruitingPhase 3Ages 18 Years - 80 YearsAllZHOU FANGJIAN
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily agree to participate in this study and sign the informed consent form; 2. Males or females between 18 years old and 80 years old; 3. Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination 4. CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1; 5. ECOG performance status: 0 or 1 point; 6. 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. Exclusion Criteria: 1. With distant metastasis 2. Severe liver and renal dysfunction, combined with other serious diseases; 3. Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year; 4. Severe/unstable angina pectoris; uncontrolled hypertension; 5. Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification; 6. Ventricular arrhythmia requiring drug treatment.
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What it tests

  • Axitinib plus Toripalimab
  • nephrectomy
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Where

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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