Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 255
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
This prospective observational study (PKU-ESCC-Monitor) aims to characterize the dynamic evolution of esophageal squamous cell carcinoma (ESCC) using integrated multi-omics, including tissue genomics, ctDNA, imaging features, immune profiling and microbiome. Two cohorts will be followed: a peri-operative cohort after standard neoadjuvant therapy and surgery, and an advanced cohort receiving first-line immunotherapy. Clinical outcomes (DFS/PFS/OS) and biomarker dynamics will be analyzed to improve risk stratification and response prediction.
详细描述
The study integrates clinical data with multi-omics (tumor tissue, surgical specimens, archived FFPE slides where applicable, serial blood for ctDNA and cytokines such as IL-6/IL-8, and exploratory immune/microbiome assessments). Patients are followed monthly or per routine visits up to 36-60 months. Analyses include RECIST 1.1-based responses (ORR, DCR, TTR, DOR), survival endpoints, and biomarker-clinical modeling to delineate ESCC evolutionary patterns and treatment response.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peri-operative cohort:
- •Age ≥18 and <80 years; ECOG 0-
- •Histologically confirmed ESCC.
- •Completed standard neoadjuvant therapy and planned/underwent 4.transthoracic esophagectomy with routine surgical specimens available.
- •5.Able to provide clinical course/outcomes and comply with follow-up at participating sites.
- •Advanced first-line immunotherapy cohort:
- •Age ≥18 and <80 years; ECOG 0-
- •Histologically confirmed ESCC, or highly suspected by endoscopy/imaging when surgery is not feasible.
- •No prior systemic anti-cancer therapy for advanced disease; archived FFPE slides (3-5 µm, 5-8 slides) acceptable if fresh tissue unavailable.
- •Able to provide clinical information and comply with follow-up.
排除标准
- •Prior anti-cancer therapy (except standard neoadjuvant therapy in the peri-operative cohort).
- •Other malignancy within 5 years (exceptions: non-melanoma skin cancer, in-situ melanoma, in-situ cervical cancer).
- •Inadequate clinical information.
- •Known infection with HIV, HBV, HCV, or syphilis.
- •Pre-operative imaging indicates insufficient tumor tissue (no visible target region) for study procedures.
- •Any condition deemed by investigators to make the patient unsuitable.
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: up to 60 months
peri-operative cohort; time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.
Overall Survival (OS)
时间窗: up to 60 months
time from study registration to death from any cause.
Progression-Free Survival (PFS)
时间窗: up to 36 months
advanced cohort;time from start of first-line therapy to first documented disease progression per RECIST 1.1 or death.
次要结局
- Time to Response (TTR)(up to 60 months)
- Objective Response Rate (ORR)(best overall response up to 24 months; proportion with CR/PR by RECIST 1.1.)
- Biomarker Analyses(baseline to 36-60 months)
- Disease Control Rate (DCR)(up to 24 months; proportion with CR/PR/SD by RECIST 1.1.)