Neoadjuvant, Renal Cell Carcinoma
Conditions
Brief 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.
Detailed description
Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.
Interventions
Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.
PROCEDUREnephrectomy
nephrectomy
Sponsors
ZHOU FANGJIAN
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival (DFS) | 2 years | To evaluate the efficacy of the neoadjuvant combination of axitinib plus PD-1 in improving the 2-year disease-free survival (DFS) in RCC patients with high-risk for recurrent (T2G3-4 or T3-4, or N1). Disease-free survival (DFS) is defined as time from registration to disease progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The cancer-specific survival (CSS) | 3 years | cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer. |
| overall survival (OS) | 3 years | overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause |
| objective response rate (ORR) | 3 years | CR and PR rate as assessed by RECIST 1.1 |
| major pathological response (MPR) | 3 years | MPR (≤10% viable malignant cells per local pathology assessment) |
| adverse event management | 3 years | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
China
Contacts
CONTACTZhiling Zhang, Professor
PRINCIPAL_INVESTIGATORFangjian Zhou, Professor
Director of Dept. of Urology, Sun Yat-sen University Cancer Center
Outcome results
None listed