The goal of this trial is to test whether patients with stage III papillary renal cell carcinoma (pRCC) could benefit from adjuvant therapy or not. The investigators invented a multi-classifier system that was successfully categorise patients with stage III pRCC into high-risk and low-risk groups. Here the investigators randomly assign classifier-defined high risk patients of stage III pRCC into adjuvant pembrolizumab group placebo group. Disease-free survival and overall survival are the end points of observation.
Histological confirmation of pRCC
With confirmed diagnosis of stage III pRCC
Classified as high-risk by multi-classifier system
With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
Patients with Transcription factor enhancer 3(TFE3) or transcription factor EB (TFEB) translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH)
Previously received neoadjuvant therapy
With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
With bad compliance or contraindication to enrollment.
Parallel
Pembrolizumab
DrugIntravenous infusion
Placebo
DrugIntravenous infusion
Disease-free survival
Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.
Overall survival
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.
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