Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738694
• Other study ID #: 2021-FXY-518
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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