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

• Status: Not yet recruiting
• Trial end date: 2030-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• 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.

• Receive radical operation for renal cancer with negative margin.

• Receive no anti-cancer treatment before primary surgery.

• The informed consent has been obtained from the patient.

Exclusion Criteria:

• 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.

• Pregnant woman or lactating woman.

• With contraindication to receive pembrolizumab, such as had a prior solid organ transplant, has a known history of human immunodeficiency virus infection.