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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05738694
Other study ID # 2021-FXY-518
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 19, 2023
Est. completion date March 16, 2026

Study information

Verified date May 2023
Source Sun Yat-sen University
Contact Zhiling Zhang, Professor
Phone +86-020-87343860
Email zhangzhl@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 246
Est. completion date March 16, 2026
Est. primary completion date July 16, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Procedure:
nephrectomy
nephrectomy

Locations

Country Name City State
China Cancer Hospital Chinese Academy of Medical Sciences Beijing
China Peking University First Hospital Beijing
China Sun Yat-sen University Cancer Center Guangzhou
China Anhui Provincial Hospital Hefei
China Fudan University Cancer Hospital Shanghai
China West China Hospital Sichuan
China Tianjin Medical University Cancer Institute and Hospital Tianjin
China The First Affiliated Hospital of Zhengzhou Hospital Zhengzhou

Sponsors (2)

Lead Sponsor Collaborator
ZHOU FANGJIAN Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease-free survival (DFS) 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. 2 years
Secondary The cancer-specific survival (CSS) cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer. 3 years
Secondary overall survival (OS) overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause 3 years
Secondary objective response rate (ORR) CR and PR rate as assessed by RECIST 1.1 3 years
Secondary major pathological response (MPR) MPR (=10% viable malignant cells per local pathology assessment) 3 years
Secondary adverse event management Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 3 years
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