简要介绍
这是一项分期未标注的注册临床试验,评估细胞治疗用于头颈部肿瘤、头颈部鳞癌的安全性、可行性及初步疗效。当前状态:招募中。计划入组 30 例。试验地点:中国 · 竹北(共 1 个中心,其中中国 1 个)。登记号:NCT06678724。
入组条件决定能不能参加
不限性别 · ≥ 20 Years
纳入标准(须全部符合):ECOG体能状态0-2分;年龄≥20岁;病理确诊口咽、口腔、下咽或喉部鳞状细胞癌,且疾病复发或转移、局部治疗无法治愈;至少有一个符合RECIST 1.1的可测量肿瘤病灶;治疗期间病历资料可获得。排除标准:治疗期间病历资料无法获得;不能配合采血;未签署知情同意。
核对登记原文(英文)
Inclusion Criteria: must fulfill with all the items below
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
* \>=20 years old.
* had pathologically confirmed squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx that was recurrent or metastatic and not curable by local therapy.
* had at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Medical records during treatment are available.
Exclusion Criteria:
* Medical records during treatment unavailable
* Could not cooperate with blood sampling
* Without informed consent
以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。
研究终点衡量什么算有效
- 主要终点无进展生存期(PFS)从入组至首次记录到疾病进展或任何原因死亡,以先发生者为准;最长评估60个月。
- 次要终点总生存期(OS)
核对登记原文(英文)
主要终点:Progression-free survival (PFS) · The time from diagnosis as non-curable disease to clinically (physical examination or radiographically) confirmed disease progression or death from any cause, whichever came first. · From enrollment to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
次要终点:Overall survival (OS)
研究设计怎么做的
- 研究类型
- 观察性研究
- 入组人数
- 30 人(预计)
核对分组登记原文(英文)
- Recurrent/Metastatic squamous cell carcinoma of the head and neck · Patient inclusion criteria, must fulfill with all the items below
1\. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.\>=20 years old.
3\. had pathologically confirmed squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx that was recurrent or metastatic and not curable by local therapy.
4\. had at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 5. Medical records during treatment are available.
关键日期
- 开始日期
- 2025-01-01
- 主要完成日期
- 2027-12-31
- 全部完成日期
- 2027-12-31
- 登记状态核实于
- 2026-02
联系与责任方
- 申办方
- National Taiwan University Hospital
- 合作方
- National Taiwan University Hospital Hsin-Chu Branch、National Taiwan University Hospital, Yun-Lin Branch
- 联系邮箱
- G04187@hch.gov.tw
- 联系电话
- +886-3-5326151
登记简述
本观察性研究旨在了解循环肿瘤栓(CTM)对复发/转移性头颈癌患者的预后价值,以及不同治疗方式和药物引起的肿瘤微环境变化。研究将分析循环肿瘤细胞(CTC)、CTM及CTM中的NK细胞组成与临床结局和患者预后的关系,并分析CTM中的NK细胞及其他免疫细胞组成与治疗效果的关联。复发/转移性头颈癌患者在知情同意后入组,研究者将在其主治医生提供治疗期间采集血液样本进行分析。
核对登记原文(英文)
The goal of this observational study is to learn about the prognostic value of circulation tumor emboli (CTM) in recurrent/metastatic head and neck cancer patients and also the changes of tumor microenvironment by different treatment modalities and drugs. The main questions it aims to answer are:
1. Investigators plan to correlate circulating tumor cells (CTC), circulating tumor emboli (CTM), and the composition of NK cells in CTM with clinical outcomes and establish their association with patient prognosis.
2. Investigators plan to understand the composition of NK cells and the immune cell components within CTM, and correlate these findings with treatment efficacy.
Patients with recurrent/metastatic head and neck cancer will be included after informed consent and investigators will collect blood samples for analysis from them under the treatment provided by their primary care physicians.