RecruitingPhase 3NCT05738694

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

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

Sponsor

ZHOU FANGJIAN

Enrollment

298 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma Neoadjuvant

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

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.

Exclusion Criteria6

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.

Interventions

DRUGAxitinib plus Toripalimab

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.

PROCEDUREnephrectomy

nephrectomy