Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Placebo

Treatment groups

468 Participants
are divided into 2 treatment groups

Locations

This trial has no locations