This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of pembrolizumab combined with axitinib as neoadjuvant therapy for locally advanced non-metastatic clear cell renal cell carcinoma.
This study is design to prospectively investigate the safety and efficacy of pembrolizumab combined with axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid on days 1-21 combined with pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
PD-1 inhibitor,Pembrolizumab 200mg IV, every 3 weeks.
Tyrosine kinase inhibitor,licensed for use in treatment of renal cell carcinoma. Oral treatment Axitinib given 5 mg PO BID.
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China
Major Pathologic Response (MPR)
The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), MPR is defined as %RVT\<10%
Time frame: 12 weeks
Pathologic Complete Response (pCR)
The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), pCR is defined as %RVT\<0%
Time frame: 12 weeks
Objective response rate (ORR)
Rate of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and immune-related response criteria (IRC)
Time frame: 12 weeks
Disease-free survival(DFS)
DFS is defined as the time from treatment to recurrence of tumor or death
Time frame: Up to 24 months
Overall survival(OS)
OS is defined as the time from treatment to death
Time frame: Up to 24 months
Incidence of treatment-related adverse events(AEs)
To be assessed by CTCAE v5.0
Time frame: Up to 24 months
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