Condition: High-grade Salivary Gland Carcinoma · Sponsor: Myung-Ju Ahn
1. Primary Objective: \- Major pathologic response rate defined by ≤ 10% of tumor composed of viable tumor 2. Secondary Objectives: * Complete resection rate * Response rate to neoadjuvant therapy according to RECIST 1.1 * Downstaging at pathologic staging compared to clinical staging performed at study entry * Distant metastasis free survival (DMFS) rate at 2 years * Disease free survival at 2 years * Overall survival rate at 2 years * Safety and feasibility 3. Exploratory Objectives: * PD L1 expression by 28-8 immunohistochemistry * IHC (HER2, AR, etc) * Whole exome sequencing (WES) * Whole transcriptome sequencing (WTS) * Peripheral blood biomarkers (CD4+ T cells, CD8+ T cell, myeloid derived suppressor cells (MDSC), Treg etc) * Interferon gamma related gene expression profile * Multiplex florescence measure of tumor cells and tumor microenvironment cells
This description comes directly from the study's public registry record.
Myung-Ju Ahn, Ph.D. · +82-2-3410-1359 · silk.ahn@samsung.com
HyeJung Chae · +82-2-3410-1359 · hj33.chae@sbri.co.kr
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| Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05727410