Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06146777

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

Interventionnel

Phase 3

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Dernière synchronisation : 29 novembre 2023
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

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.

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Catégorie de traitement

Autres médicaments, Inhibiteurs de points de contrôle

Mutations requises

Aucun

Essai commencé

1 décembre 2023

Dernière mise à jour par le sponsor

29 novembre 2023

Achèvement estimé

1 décembre 2030

Contact de l'étude

Nom:Jun-Hang Luo, M.D.

E-mail:luojunh@mail.sysu.edu.cn

Téléphone:+862087755766

Éligibilité

Critères d'inclusion

* 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.

Critères d'exclusion

* 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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Détails de la conception

AllocationRandomized

Modèle d'interventionParallel Assignment

MasquageNone (Open Label)

Nombre à inscrire468

Bras et interventions

Bras

Interventions

Type : Experimental

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

Interventions :

Placebo
Pembrolizumab

Mesures des résultats

Mesures des résultats primaires

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.

Mesures des résultats secondaires

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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