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

NCT ID: NCT05738694

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2027-12-31

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.

Conditions

Renal Cell Carcinoma; Neoadjuvant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant group

Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy

Group Type: EXPERIMENTAL

Axitinib plus Toripalimab

Intervention Type: DRUG

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.

nephrectomy

Intervention Type: PROCEDURE

nephrectomy

Control group

The control group will be given nephrectomy alone.

Group Type: ACTIVE_COMPARATOR

nephrectomy

Intervention Type: PROCEDURE

nephrectomy

Interventions

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.

Intervention Type: DRUG

nephrectomy

nephrectomy

Intervention Type: PROCEDURE

Other Intervention Names

nephrectomy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

ZHOU FANGJIAN

OTHER

Sponsor Role: lead

Responsible Party

ZHOU FANGJIAN

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fangjian Zhou, Professor

Role: PRINCIPAL_INVESTIGATOR

Director of Dept. of Urology, Sun Yat-sen University Cancer Center

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Peking University First Hospital

Beijing, , China

Site Status: RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status: RECRUITING

Anhui Provincial Hospital

Hefei, , China

Site Status: RECRUITING

Fudan University Cancer Hospital

Shanghai, , China

Site Status: RECRUITING

West China Hospital

Sichuan, , China

Site Status: RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

The First Affiliated Hospital of Zhengzhou Hospital

Zhengzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiling Zhang, Professor

Role: CONTACT

zhangzhl@sysucc.org.cn

+86-020-87343860

Facility Contacts

Sujun Han, Dr

Role: primary

Zhisong He, Dr

Role: primary

Zhiling Zhang, Dr

Role: primary

JUn Xiao, Dr

Role: primary

Hailiang Zhang, Dr

Role: primary

Hao Zeng, Dr

Role: primary

Yao Xin, Dr

Role: primary

Xuepei Zhang, Dr

Role: primary

Other Identifiers

2021-FXY-518

Identifier Type: -

Identifier Source: org_study_id