Tests axitinib and toripalimab before surgery for kidney cancer
Tests axitinib with toripalimab before kidney removal in adults with kidney cancer.
Key facts
- Who runs it
- ZHOU FANGJIAN
- Where
- Beijing, Guangzhou, Hefei, Shanghai, Sichuan, Tianjin, and Zhengzhou, ChinaSee the 8 sites
- Trial code
- Registry title
- Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 298 people, planned
- Started
- 19 Apr 2023
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Axitinib plus Toripalimab
- nephrectomy
- Record updated
- 17 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with clear cell kidney cancer at high risk of coming back after kidney removal surgery. It tests axitinib plus a PD-1 antibody before surgery against surgery alone.
- Age
- 18 to 80 years
- Sex
- Men and women can join.
- Disease stage
- Clear cell kidney cancer (or mostly clear cell), seen on CT or MRI as T2G4, T2 with sarcomatoid differentiation, T3-4 or N1, with no distant spread.
Main reasons for not taking part
- Cancer that has spread to distant parts of the body
- Severe liver or kidney problems, or other serious diseases
- Heart attack, arteritis or venous blood clot in the past 1 year
- Severe or unstable angina, or uncontrolled high blood pressure
- Class III or IV heart failure, or heart rhythm problems needing drug treatment
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Voluntarily agree to participate in this study and sign the informed consent form
- Males or females between 18 years old and 80 years old
- Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
- CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1
- ECOG performance status: 0 or 1 point
- 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
Who cannot take part
- Severe liver and renal dysfunction, combined with other serious diseases
- Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year
- Severe/unstable angina pectoris; uncontrolled hypertension
- Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification
- Ventricular arrhythmia requiring drug treatment
- With distant metastasis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaContact: Sujun Han, DrTaking people
- Peking University First HospitalBeijing, ChinaContact: Zhisong He, DrTaking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Zhiling Zhang, DrTaking people
- Anhui Provincial HospitalHefei, ChinaContact: JUn Xiao, DrTaking people
- Fudan University Cancer hospitalShanghai, ChinaContact: Hailiang Zhang, DrTaking people
- West China HospitalSichuan, ChinaContact: Hao Zeng, DrTaking people
- Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaContact: Yao Xin, DrTaking people
- The First Affiliated Hospital of Zhengzhou HospitalZhengzhou, ChinaContact: Xuepei Zhang, DrTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Neoadjuvant groupTreatment being tested
Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy
Treatment: Axitinib plus Toripalimab and nephrectomy
- Control groupExisting treatment, for comparison
The control group will be given nephrectomy alone.
Treatment: nephrectomy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests axitinib and toripalimab before surgery for kidney cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05738694, who can take part
- Record updated
- 17 March 2026