Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Study Details
Study Description
Brief Summary
The study included 110 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1) or oligometastasis who were scheduled to receive radical topical therapy (M1 NEG). 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 110 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1) or oligometastasis who were scheduled to receive radical topical therapy (M1 NEG). 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neoadjuvant group Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + radical nephrectomy |
Drug: Axitinib plus Toripalimab
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.
Other Names:
Procedure: radical nephrectomy
radical nephrectomy
|
| Active Comparator: Control group The control group will be given radical nephrectomy alone. |
Procedure: radical nephrectomy
radical nephrectomy
|
Outcome Measures
Primary Outcome Measures
- 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 or M1 NEG). Disease-free survival (DFS) is defined as time from registration to disease progression or death.
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males or females between 18 years old and 80 years old;
-
Histopathologically confirmed clear cell carcinoma;
-
Staged as T2G3-4 or T3-T4 or N1 or M1 NEG (less than 5 metastases, planned to receive radical Treatment of metastases within 12 weeks after surgery).
Exclusion Criteria:
-
Brain, liver or bone metastases;
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ZHOU FANGJIAN
- Pfizer
Investigators
- Principal Investigator: Fangjian Zhou, Professor, Director of Dept. of Urology, Sun Yat-sen University Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-FXY-518