Actively Recruiting
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Led by ZHOU FANGJIAN · Updated on 2026-03-17
298
Participants Needed
8
Research Sites
245 weeks
Total Duration
On this page
Sponsors
Z
ZHOU FANGJIAN
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 80 years
- Diagnosed with clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma by histopathology
- Clinical staging by CT or MRI showing T2G4 or T2 with sarcomatoid differentiation, T3-4, or N1
- ECOG performance status of 0 or 1
- Adequate heart, bone marrow, liver, and kidney functions: cardiac function class 0-2; white blood cell count ≥3.5×10⁹/L; absolute neutrophil count ≥1.5×10⁹/L; platelets ≥75.0×10⁹/L; hemoglobin ≥80 g/L; total bilirubin ≤1.5 times upper limit of normal; AST and ALT ≤2.5 times upper limit of normal; glomerular filtration rate ≥45 ml/min
You will not qualify if you...
- Presence of distant metastasis
- Severe liver or kidney dysfunction or other serious diseases
- Serious cardiovascular disease including myocardial infarction, arteritis, or venous thrombosis within the past year
- Severe or unstable angina pectoris or uncontrolled hypertension
- New York Heart Association Class III or IV heart failure
- Ventricular arrhythmia requiring drug treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
Peking University First Hospital
Beijing, China
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
4
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
5
Fudan University Cancer Hospital
Shanghai, China
Actively Recruiting
6
West China Hospital
Sichuan, China
Actively Recruiting
7
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Actively Recruiting
8
The First Affiliated Hospital of Zhengzhou Hospital
Zhengzhou, China
Actively Recruiting
Research Team
Z
Zhiling Zhang, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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