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

RecruitingPhase 3

Sponsor: ZHOU FANGJIAN

Conditions: Renal Cell Carcinoma, Neoadjuvant

Interventions: Axitinib plus Toripalimab, nephrectomy

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (8)

Beijing, China
Beijing, China
Guangzhou, China
Hefei, China
Shanghai, China
Sichuan, China
Tianjin, China
Zhengzhou, China