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Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04118855
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date October 8, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
Objective Tumor Response Rate [ Time Frame: 3 month ]
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • Safety assessed by adverse events [ Time Frame: through study completion, an average of 4 months ]
    Safety as assessed by number of participants experiencing adverse events
  • Perioperative complication rate [ Time Frame: from perioperative to 90 days after surgery ]
    Perioperativecomplications judged by Clavien-Dindo classification
  • Quality of Life questionnaire [ Time Frame: Baseline, 3 weeks, 12 weeks and after surgery ]
    Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
  • Tumor complexity changing by total R.E.N.A.L. score [ Time Frame: Baseline, 12 weeks ]
    R.E.N.A.L. Nephrometry Score) to quantify the anatomical characteristics of renal R.E.N.A.L. score consists of 5 anatomical features, and sum them up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Official Title  ICMJE Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Brief Summary This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.
Detailed Description This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Toripalimab
    3mg/kg, IV (in the vein) on on day 1 of 3-week, 6-week and 9-week for a total of 3 doses prior to partial nephrectomy or radical nephrectomy
    Other Name: anti-PD-1 monoclonal antibody
  • Drug: Axitinib
    5 mg by mouth twice each day for 12 weeks prior to nephrectomy
Study Arms  ICMJE Experimental: Neoadjuvant arm
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Interventions:
  • Drug: Toripalimab
  • Drug: Axitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2026
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0M0)
  • Schedule to undergo either partial or radical nephrectomy as part of treatment plan
  • ECOG performance status of 0 or 1
  • Adequate organ and marrow function defined by study-specified laboratory tests
  • Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
  • Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer

Exclusion Criteria:

  • Patients who have received other systems for anti-tumor treatment
  • Patients who have previously received targeted or immunotherapy
  • Need for urgent or emergent nephrectomy to relieve symptoms
  • Current use of immunosuppressive agents
  • Pregnant or breastfeeding women
  • History of autoimmune disease or syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: jiwei Huang, Dr 8613651682825 jiweihuang@outlook.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04118855
Other Study ID Numbers  ICMJE Neo-RCC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RenJi Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP