NCT06182657招募中不适用
The Prognostic Value of the Degree of Pathological Response at One Cycle of Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinon-a Prospective Observational Study
Jiangxi Provincial Cancer Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progress-free survival (PFS)
研究概览
简要总结
This study aims to explore the prognostic value of pathological remission after one cycle of induction chemotherapy in locally advanced nasopharyngeal carcinoma, and the change of immune micro-environment after one cycle induction chemotherapy, including the density of immune cells infiltration and tertiary lymphoid structures.
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
- 否
入选标准
- •Ability to sign informed consent
- •Age > 18 years at time of study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)
- •Histological confirmation of NPC (regardless if EBER positive or negative)
- •Locally advanced NPC, UICC stage III-IVa
- •Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
排除标准
- •Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- •Distant metastases
- •Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced NPC.
- •History of another primary malignancy
- •Female patients who are pregnant
- •Known allergy or hypersensitivity to any drugs
- •Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
结局指标
主要结局
Progress-free survival (PFS)
时间窗: 3 years
PFS is defined as the time from treatment to date of first documentation of progression or death due to any cause.
次要结局
- Overall Survival (OS)(3 years)
- Distant metastasis-free survival (DMFS)(3 years)
- Infiltrating Immune cell density(At the end of Cycle 1 (each cycle is 21 days).)
- Pathological complete response (pCR) rate(At the end of Cycle 1 (each cycle is 21 days).)
研究者
研究点 (1)
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