NCT07533357尚未招募不适用
A Prospective Study of Tpex Subsets in Negative Tumor Draining Lymph Nodes for Predicting the Efficacy of PD 1 Inhibitors in Advanced or Recurrent Esophageal Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 158
- 主要终点
- overall survival
研究概览
简要总结
The goal of this observational study is to to determine whether patients with a high proportion of precursor exhausted T cells (Tpex) in negative tumor draining lymph nodes have longer overall survival. The main question it aims to answer is: Whether precursor exhausted T cells (Tpex) in negative tumor-draining lymph nodes have better predictive efficacy for treatment response than PD-L1 CPS.
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
- •Aged ≥18 years
- •Histologically confirmed esophageal carcinoma
- •Clinical stages IV based on the 8th AJCC TNM classification, or recurrent esophageal cancer
- •plan to treated with PD-1 immunotherapy
- •Eastern Cooperative Oncology Group(ECOG) performance status: 0-2
排除标准
- •Esophageal perforation or hematemesis
- •Any active autoimmune disease or a history of autoimmune disease
- •Disease progression occurs within 3months after PD-1 immunotherapy.
- •Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 inhibitors for injection.
- •Uncontrolled heart diseases or clinical symptoms
- •Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
研究组 & 干预措施
PD-1 treatment group
PD-1 treatment group
结局指标
主要结局
overall survival
时间窗: 2 years
overall survival
次要结局
未报告次要终点
研究者
相似试验
尚未招募
1/2 期
Scope of Homeopathy in cases of Tenia corporisCTRI/2025/09/095410SAINATH HOSPITAL50
尚未招募
不适用
Thermalytix Breast imaging at KEM HospitalCTRI/2025/07/091198Dr Shilpa Rao6,000
Enrolling By Invitation
不适用
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsNCT07397390The First Affiliated Hospital of Dalian Medical University58
招募中
2 期
A Phase 2 Study of PTX-100 Monotherapy in Patients with r/r CTCL2025-521852-45-00Prescient Therapeutics Limited25
招募中
2 期
Clinical Study To Evaluate Effectiveness Of Shatavari Ghrita Aaschyotana In Computer Vision SyndromeCTRI/2025/10/096017DHARMARAJ BHUSHAN BHOITE80