Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal
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.
| Condition(s) | Renal Cell Carcinoma, Neoadjuvant |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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; |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | ZHOU FANGJIAN |
| Locations | Beijing, China; Beijing, China; Guangzhou, China; Hefei, China; Shanghai, China; Sichuan, China (+2 more sites) |
| Start date | 2023-04-19 |
| NCT ID | NCT05738694 |
| Official listing | https://clinicaltrials.gov/study/NCT05738694 |