Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma Drug: Toripalimab Drug: Axitinib Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2026


Arm Intervention/treatment
Experimental: Neoadjuvant arm
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Perioperative complication rate [ Time Frame: from perioperative to 90 days after surgery ]
    Perioperativecomplications judged by Clavien-Dindo classification

  3. 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

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04118855


Contacts
Layout table for location contacts
Contact: jiwei Huang, Dr 8613651682825 jiweihuang@outlook.com

Sponsors and Collaborators
RenJi Hospital

Layout table for additonal information
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04118855     History of Changes
Other Study ID Numbers: Neo-RCC
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

Layout table for additional information
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
Keywords provided by RenJi Hospital:
neoadjuvant therapy
Toripalimab
axitinib
nephrectomy
partial nephrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action