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

NCT06146777 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2023-11-29

No results posted yet for this study

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.

Conditions

  • Papillary Renal Cell Carcinoma

Interventions

DRUG

Pembrolizumab

Intravenous infusion

DRUG

Placebo

Intravenous infusion

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jun-Hang Luo, M.D. · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2030-12-01
Completion
2030-12-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146777 on ClinicalTrials.gov