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OncoMatch/Clinical Trials/NCT05738694

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

Is NCT05738694 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Axitinib plus Toripalimab for renal cell carcinoma.

Phase 3RecruitingZHOU FANGJIANNCT05738694Data as of May 2026

Treatment: Axitinib plus ToripalimabThe 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.

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Extracted eligibility criteria

Cancer type

Renal Cell Carcinoma

Disease stage

Required: Stage T2G4, T2 WITH SARCOMATOID DIFFERENTIATION

Grade: G4

CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

WBC≥3.5×10^9/L, absolute neutrophil count ≥1.5×10^9/L, PLT≥75.0×10^9/L, HGB≥80g/L

Kidney function

GFR ≥ 45 ml/min

Liver function

Total bilirubin ≤1.5×ULN, AST and ALT ≤2.5×ULN

Cardiac function

Cardiac function class 0-2

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×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; Renal function: GFR ≥ 45 ml/min.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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