Combining Axitinib and PD-1 to Improve Outcomes in Kidney Cancer

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

This study is testing if a combination of axitinib and PD-1 therapy can help kidney cancer patients who are at high risk of their cancer coming back after surgery.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 298 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: axitinib
• Locations: 8 sites (Beijing and 7 other locations)
• Trial ID: NCT05738694 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a neoadjuvant treatment combining axitinib and PD-1 therapy in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after nephrectomy. A total of 246 participants will be randomly assigned to receive either the combination therapy followed by surgery or surgery alone. The goal is to eliminate tumor micrometastases and enhance anti-tumor immunity, thereby improving disease-free survival rates. The study aims to provide evidence-based insights into perioperative treatment strategies for RCC patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with histopathologically confirmed clear cell carcinoma staged as T2G3-4, T3-4, or N1.

Not a fit: Patients with distant metastasis or severe comorbidities such as significant cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve disease-free survival rates for patients with high-risk renal cell carcinoma.

How similar studies have performed: Previous studies combining TKI and PD-1 therapies have shown promising results in advanced RCC, suggesting potential success for this neoadjuvant approach.

Eligibility criteria

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.

Where this trial is running

Beijing and 7 other locations

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

Study contacts

• Principal investigator: Fangjian Zhou, Professor — Director of Dept. of Urology, Sun Yat-sen University Cancer Center
• Study coordinator: Zhiling Zhang, Professor

Conditions: Renal Cell Carcinoma, Neoadjuvant