Trial Title:
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
NCT ID:
NCT05738694
Condition:
Renal Cell Carcinoma
Neoadjuvant
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Axitinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Axitinib plus Toripalimab
Description:
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.
Arm group label:
Neoadjuvant group
Other name:
nephrectomy
Intervention type:
Procedure
Intervention name:
nephrectomy
Description:
nephrectomy
Arm group label:
Control group
Arm group label:
Neoadjuvant group
Summary:
The study included 246 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 246 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males or females between 18 years old and 80 years old;
2. Histopathologically confirmed clear cell carcinoma;
3. Staged as T2G3-4 or T3-T4 or N1
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Sujun Han, Dr
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhisong He, Dr
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiling Zhang, Dr
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
JUn Xiao, Dr
Facility:
Name:
Fudan University Cancer Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Hailiang Zhang, Dr
Facility:
Name:
West China Hospital
Address:
City:
Sichuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Zeng, Dr
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Xin, Dr
Facility:
Name:
The First Affiliated Hospital of Zhengzhou Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuepei Zhang, Dr
Start date:
April 19, 2023
Completion date:
March 16, 2026
Lead sponsor:
Agency:
ZHOU FANGJIAN
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05738694
