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

NCT05738694 | Recruiting Phase 3 DMC

• 1 other identifier: 2021-FXY-518
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 8

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.

Conditions

Renal Cell Carcinoma; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The cancer-specific survival (CSS)

  3 years

• overall survival (OS)

  3 years

• objective response rate (ORR)

  3 years

• major pathological response (MPR)

  3 years

• adverse event management

  3 years

Study Arms (2)

Neoadjuvant group

EXPERIMENTAL

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

Drug: Axitinib plus Toripalimab; Procedure: nephrectomy

Control group

ACTIVE COMPARATOR

The control group will be given nephrectomy alone.

Procedure: nephrectomy

Interventions

Axitinib plus Toripalimab 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.

Also known as: nephrectomy

Neoadjuvant group

nephrectomy PROCEDURE

nephrectomy

Control group; Neoadjuvant group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agree to participate in this study and sign the informed consent form;
• Males or females between 18 years old and 80 years old;
• Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
• CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
• ECOG performance status: 0 or 1 point;
• 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.

You may not qualify if:

• With distant metastasis
• 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.

Sponsors & Collaborators

• ZHOU FANGJIAN: lead
• Pfizer: collaborator

Study Sites (8)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

Anhui Provincial Hospital

Hefei, China

RECRUITING

Fudan University Cancer Hospital

Shanghai, China

RECRUITING

West China Hospital

Sichuan, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

The First Affiliated Hospital of Zhengzhou Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib; toripalimab; Nephrectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Fangjian Zhou, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiling Zhang, Professor

CONTACT

+86-020-87343860; zhangzhl@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 22, 2023
• Study Start: April 19, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)