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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 (Jun 2026). This Phase 3 trial studies Axitinib plus Toripalimab for renal cell carcinoma.

Phase 3RecruitingZHOU FANGJIANNCT05738694Data as of Jun 2026Location: China

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

Treatments studied

Other

Axitinib plus Toripalimab

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)

Demographics

Ages ≤ 80

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.

Frequently asked questions

Is NCT05738694 currently recruiting?

Yes, this trial is currently recruiting patients.

What disease stage is eligible?

Stage T2G4 or T2 WITH SARCOMATOID DIFFERENTIATION is required.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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