Back to resultsToripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Primary Purpose
Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Axitinib
Sponsored by
About this trial
This is an interventional treatment trial for Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma focused on measuring neoadjuvant therapy, Toripalimab, axitinib, nephrectomy, partial nephrectomy
Eligibility 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
Sites / Locations
- Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant arm
Arm Description
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Outcomes
Primary Outcome Measures
Objective Tumor Response Rate
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
Secondary Outcome Measures
Safety assessed by adverse events
Safety as assessed by number of participants experiencing adverse events
Perioperative complication rate
Perioperativecomplications judged by Clavien-Dindo classification
Quality of Life questionnaire
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04118855
Brief Title
Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
Keywords
neoadjuvant therapy, Toripalimab, axitinib, nephrectomy, partial nephrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant arm
Arm Type
Experimental
Arm Description
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
anti-PD-1 monoclonal antibody
Intervention Description
240mg, 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
Intervention Type
Drug
Intervention Name(s)
Axitinib
Intervention Description
5 mg by mouth twice each day for 12 weeks prior to nephrectomy
Primary Outcome Measure Information:
Title
Objective Tumor Response Rate
Description
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Safety assessed by adverse events
Description
Safety as assessed by number of participants experiencing adverse events
Time Frame
through study completion, an average of 4 months
Title
Perioperative complication rate
Description
Perioperativecomplications judged by Clavien-Dindo classification
Time Frame
from perioperative to 90 days after surgery
Title
Quality of Life questionnaire
Description
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
Time Frame
Baseline, 3 weeks, 12 weeks and after surgery
Title
Tumor complexity changing by total R.E.N.A.L. score
Description
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.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
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
Facility Information:
Facility Name
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
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