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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05738694
Recruitment Status : Recruiting
First Posted : February 22, 2023
Last Update Posted : May 9, 2023
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ZHOU FANGJIAN, Sun Yat-sen University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Neoadjuvant Drug: Axitinib plus Toripalimab Procedure: nephrectomy Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 19, 2023
Estimated Primary Completion Date : July 16, 2025
Estimated Study Completion Date : March 16, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neoadjuvant group
Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy
 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.
Other Name: nephrectomy

Procedure: nephrectomy
nephrectomy
Active Comparator: Control group
The control group will be given nephrectomy alone.
 Procedure: nephrectomy
nephrectomy


Outcome Measures
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Primary Outcome Measures :
  1. disease-free survival (DFS) [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. The cancer-specific survival (CSS) [ Time Frame: 3 years ]
    cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer.

  2. overall survival (OS) [ Time Frame: 3 years ]
    overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause

  3. objective response rate (ORR) [ Time Frame: 3 years ]
    CR and PR rate as assessed by RECIST 1.1

  4. major pathological response (MPR) [ Time Frame: 3 years ]
    MPR (≤10% viable malignant cells per local pathology assessment)

  5. adverse event management [ Time Frame: 3 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05738694


Contacts
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Contact: Zhiling Zhang, Professor +86-020-87343860 zhangzhl@sysucc.org.cn

Locations
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China
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Sujun Han, Dr         
Peking University First Hospital Recruiting
Beijing, China
Contact: Zhisong He, Dr         
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, China
Contact: Zhiling Zhang, Dr         
Anhui Provincial Hospital Recruiting
Hefei, China
Contact: JUn Xiao, Dr         
Fudan University Cancer Hospital Recruiting
Shanghai, China
Contact: Hailiang Zhang, Dr         
West China Hospital Recruiting
Sichuan, China
Contact: Hao Zeng, Dr         
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, China
Contact: Yao Xin, Dr         
The First Affiliated Hospital of Zhengzhou Hospital Recruiting
Zhengzhou, China
Contact: Xuepei Zhang, Dr         
Sponsors and Collaborators
ZHOU FANGJIAN
Pfizer
Investigators
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Principal Investigator: Fangjian Zhou, Professor Director of Dept. of Urology, Sun Yat-sen University Cancer Center
More Information
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Responsible Party: ZHOU FANGJIAN, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05738694    
Other Study ID Numbers: 2021-FXY-518
First Posted: February 22, 2023    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
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
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action