Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Recruiting now · Phase 3
Conditions studied: Renal Cell Carcinoma, Neoadjuvant
In brief
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.
Key facts
- Study ID
- NCT05738694
- Run by
- ZHOU FANGJIAN
- People needed
- 298
- Starts
- 2023-04-19
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- With distant metastasis
- 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.
Where it is running
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (enrolling)
- Peking University First Hospital — Beijing, China (enrolling)
- Sun Yat-sen University Cancer Center — Guangzhou, China (enrolling)
- Anhui Provincial Hospital — Hefei, China (enrolling)
- Fudan University Cancer Hospital — Shanghai, China (enrolling)
- West China Hospital — Sichuan, China (enrolling)
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (enrolling)
- The First Affiliated Hospital of Zhengzhou Hospital — Zhengzhou, China (enrolling)
Full record on ClinicalTrials.gov
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