NCT05738694RecruitingPhase 3
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 298 (estimated)
- First submitted
- 11 Jan 2023
- Start date
- 19 Apr 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- ZHOU FANGJIAN
- Diseases
- Kidney cancer
- NCT number
- NCT05738694
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 298
- From 19 Apr 2023 to the primary completion date, 31 Dec 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- With distant metastasis
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Fudan University Cancer hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| West China Hospital Coordinator of this site? Confirm its status | Sichuan | China | Recruiting |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.