In patients with recurrent or metastatic renal cell carcinoma, a preliminary evaluation of the safety and efficacy of sintilimab combined with axitinib in patients with advanced renal cell carcinoma was conducted.Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and disease remission rate (ORR) were evaluated.
Patients with recurrent or metastatic renal cell carcinoma received axitinib tablets (5mg bid po) combined with sintilimab (200mg d1) on a 3-week (21-day) as a one-cycle regimen.6 months of continuous administration (i.e., 8 cycles of sintilimab) or until tumor progression or unacceptable toxicity or death or subject withdraws informed consent;If the drug has been discontinued or the tumor has progressed, and there are no intolerable side effects, the drug can be continued according to the judgment of the researchers and the will of the subjects. Drug safety was evaluated before each cycle.The first efficacy was evaluated after 2 cycles.The efficacy was then evaluated every 2 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PD-1 inhibitor,Sintilimab 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
Overall response rate (ORR)
To be assessed by RECIST 1.1
Time frame: Up to 12 months
Progression free survival (PFS)
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
Time frame: From randomization up to 3 years.
Overall Survival (OS)
OS is the time from date of randomization to date of death due to any cause.
Time frame: Every 3 months up to 3 years.
Disease Control Rate (DCR)
DC is defined as complete response (CR), partial response (PR), or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause.
Time frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 3 years from randomization
Incidence of treatment-related adverse events
To be assessed by CTCAE v4.03.
Time frame: Up to 3 years.
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