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

Last updated: March 15, 2026
Sponsor: ZHOU FANGJIAN
Overall Status: Active - Recruiting

Phase

3

Condition

Carcinoma

Cancer/tumors

Renal Cell Carcinoma

Treatment

nephrectomy

Axitinib plus Toripalimab

Clinical Study ID

NCT05738694
2021-FXY-518
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 ofclear 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

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: myocardialinfarction or arteritis or venous thrombosis (such as pulmonary embolism) in thepast 1 year;

  4. Severe/unstable angina pectoris; uncontrolled hypertension;

  5. Class III or IV heart failure by New York Heart Association (NYHA) FunctionalClassification;

  6. Ventricular arrhythmia requiring drug treatment.

Study Design

Total Participants: 298
Treatment Group(s): 2
Primary Treatment: nephrectomy
Phase: 3
Study Start date:
April 19, 2023
Estimated Completion Date:
December 31, 2027

Study Description

Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing,
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing 1816670,
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670,
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou,
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou 1809858,
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei,
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei 1808722,
    China

    Site Not Available

  • Fudan University Cancer Hospital

    Shanghai,
    China

    Active - Recruiting

  • Fudan University Cancer Hospital

    Shanghai 1796236,
    China

    Site Not Available

  • West China Hospital

    Sichuan,
    China

    Active - Recruiting

  • West China Hospital

    Sichuan 7348569,
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin,
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin 1792947,
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou Hospital

    Zhengzhou 1784658,
    China

    Site Not Available

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