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临床试验/NCT07448727
NCT07448727招募中不适用

Prospective Observational Study On The Impact Of Early Response To First-line Anti-PD-1 Therapy In Patients With Recurrent And/Or Metastatic (R/M) Head And Neck Squamous Cell Carcinoma, Assessed By 18F-FDG PET/CT

University of Rome Tor Vergata1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年11月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab

研究概览

简要总结

This study aims to evaluate the role of early response assessment by 18F-FDG PET/CT in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma with PD-L1 CPS >1 treated with pembrolizumab monotherapy, in accordance with routine clinical practice.

详细描述

Eligible patients will receive two administrations of Pembrolizumab as monotherapy.

An 18F-FDG PET/CT scan will be performed at baseline (T0; no more than 30 days before the first drug administration) and after two cycles (T1, at 6 weeks).

Patients will be considered responders if they achieve a complete response (defined as complete resolution of FDG uptake within the target lesions) or a partial response (i.e., >=30% decrease in the target tumor FDG SULpeak).

After the first two administrations of Pembrolizumab, as well as in case of progressive disease (i.e., >=30% increase in the target tumor FDG SULpeak or advent of new 18FDG-avid lesions), any treatment modification will be determined by the physician according to routine clinical practice

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histological diagnosis of recurrent and/or metastatic HNSCC, not amenable for curative locoregional treatment (either surgery or radiotherapy), and amenable for first line systemic treatment
  • CPS PD-L1 >=1

排除标准

  • Any controindication to immune checkpoint inhibitors

结局指标

主要结局

Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab

时间窗: through study completion, an average of 1 year

To evaluate whether changes in metabolic activity on 18F-FDG PET/CT at 6 weeks predict response to pembrolizumab monotherapy at 3, 6, and 9 months in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC).

次要结局

未报告次要终点

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincenzo Formica

Professor

University of Rome Tor Vergata

研究点 (1)

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