NCT05697926招募中不适用
Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical prognosis
研究概览
简要总结
This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender is not limited, age 18-75 years old;
- •Estimated survival is greater than 3 months;
- •Newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment;
- •Patients with head and neck cancer whose tumor tissue can be surgically harvested;
- •Volunteer to join the study and sign the informed consent.
排除标准
- •Infected or had been infected with COVID-19;
- •Active hepatitis B or C virus, HIV infection, or other uncured active infected persons;
- •Patients with head and neck cancer who had received the following treatments:
- •The patient had a history of using PD-1 and other immune checkpoint inhibitors 8 weeks before surgery; History of chemotherapy drug use 8 weeks before surgery; A history of hormone drug use within 4 weeks before surgery;
- •Other situations that are not appropriate to be included in the clinical trial.
结局指标
主要结局
Clinical prognosis
时间窗: 5 year postsurgery
Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival.
次要结局
未报告次要终点
研究者
研究点 (1)
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