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

ZHOU FANGJIAN

Status and phase: Enrolling; Phase 2

Conditions: Neoadjuvant; Renal Cell Carcinoma

Treatments: Procedure: nephrectomy; Drug: Axitinib plus Toripalimab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05738694

2021-FXY-518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 298 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 of clear 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 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: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
4. Severe/unstable angina pectoris; uncontrolled hypertension;
5. Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
6. Ventricular arrhythmia requiring drug treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 2 patient groups

Neoadjuvant group

Experimental group

Description:

Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy

Treatment:

Drug: Axitinib plus Toripalimab

Procedure: nephrectomy

Control group

Active Comparator group

Description:

The control group will be given nephrectomy alone.

Treatment:

Procedure: nephrectomy