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Recruiting NCT05738694

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

Phase III Interventional Renal Cell Carcinoma Neoadjuvant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Axitinib plus Toripalimab, nephrectomy.
Who it may be relevant to
Registry conditions: Renal Cell Carcinoma, Neoadjuvant. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • Drug Axitinib 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.
  • Procedure nephrectomy
    nephrectomy

Primary outcome measures

  • disease-free survival (DFS) [Time frame: 2 years]
Secondary outcome measures (5)
  • The cancer-specific survival (CSS) [Time frame: 3 years]
  • overall survival (OS) [Time frame: 3 years]
  • objective response rate (ORR) [Time frame: 3 years]
  • major pathological response (MPR) [Time frame: 3 years]
  • adverse event management [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 8 centers
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Peking University First Hospital — Beijing
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Anhui Provincial Hospital — Hefei
  • Fudan University Cancer Hospital — Shanghai
  • West China Hospital — Sichuan
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin
  • The First Affiliated Hospital of Zhengzhou Hospital — Zhengzhou

Identifiers

NCT: NCT05738694 · 2021-FXY-518

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗