Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06146777

Non recluta ancora

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

Interventistico

Fase 3

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Ultimo Aggiornamento: 29 novembre 2023
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri Farmaci, Inibitori dei Checkpoint

Mutazioni richieste

Nessuno

Studio Iniziato

1 dicembre 2023

Ultimo Aggiornamento dello Sponsor

29 novembre 2023

Completamento Stimato

1 dicembre 2030

Contatto dello studio

Nome:Jun-Hang Luo, M.D.

Email:luojunh@mail.sysu.edu.cn

Telefono:+862087755766

Idoneità

Criteri di Inclusione

* 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.

Criteri di Esclusione

* 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.

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare468

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for up to 17 cycles.

Interventi:

Placebo
Pembrolizumab

Misure di Esito

Misure di Esito Primarie

Disease-free survivalFrom the date of registration to up to 7 years

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.

Misure di Esito Secondarie

Overall survivalFrom the date of registration to up to 7 years

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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