Actively Recruiting
Neoadjuvant Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease-Free Survival in Patients With Renal Cell Carcinoma: A Multicenter Randomized Controlled Study
Led by ZHOU FANGJIAN · Updated on 2026-03-17
298
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
ZHOU FANGJIAN
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the neoadjuvant combination of axitinib plus PD-1 immunotherapy to improve disease-free survival in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after nephrectomy. This Phase 3 randomized controlled study includes 298 patients with advanced tumor stages or lymph node involvement and aims to provide evidence for better perioperative treatment strategies. Participants are randomly assigned to one of two groups: one receives preoperative axitinib orally twice daily for 3 months combined with four cycles of Toripalimab (a PD-1 monoclonal antibody) every 3 weeks before nephrectomy, while the control group undergoes nephrectomy alone. The study compares the effectiveness of adding this neoadjuvant drug combination to surgery versus surgery by itself. Throughout the study, patients will be monitored for disease-free survival over 2 years, as well as cancer-specific survival, overall survival, response rates, pathological responses, and management of adverse events over 3 years. Clinical assessments include imaging, laboratory tests, and safety evaluations. The study started in April 2023 and will continue until the end of 2027, providing comprehensive long-term follow-up for participants.
CONDITIONS
Brief 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 between 18 and 80 years
- Diagnosed with clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma confirmed by histopathology
- Clinical stage T2G4 or T2 with sarcomatoid differentiation, T3-4, or N1 by CT or MRI
- ECOG performance status 0 or 1
- Sufficient heart, bone marrow, liver, and kidney functions, including cardiac function class 0-2; WBC ≥3.5×10^9/L; absolute neutrophil count ≥1.5×10^9/L; platelets ≥75.0×10^9/L; hemoglobin ≥80 g/L; total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN; GFR ≥45 ml/min
You will not qualify if you...
- Presence of distant metastasis
- Severe liver or renal dysfunction or other serious diseases
- Serious cardiovascular disease such as myocardial infarction, arteritis, or venous thrombosis within the past year
- Severe or unstable angina pectoris
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants in the neoadjuvant group receive axitinib orally twice daily for 3 months and Toripalimab by infusion every 3 weeks for 4 cycles before surgery.
Monthly visits for treatment administration and monitoring
Duration - 1 day
Participants undergo nephrectomy to remove the kidney tumor.
1 surgical visit (in-person)
Duration - Up to 3 years
Participants are monitored for disease-free survival and other clinical outcomes for up to 3 years after surgery.
Regular follow-up visits during the 3 years post-surgery
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
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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