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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Fangjian Zhou, Professor — Director of Dept. of Urology, Sun Yat-sen University Cancer Center
• Study coordinator: Zhiling Zhang, Professor
• Email: zhangzhl@sysucc.org.cn
• Phone: +86-020-87343860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.