Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor (NCT07152535) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
255 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and \<80 years; ECOG 0-1.
✓. Histologically confirmed ESCC.
✓. Completed standard neoadjuvant therapy and planned/underwent 4.transthoracic esophagectomy with routine surgical specimens available.
✓.Able to provide clinical course/outcomes and comply with follow-up at participating sites.
✓. Age ≥18 and \<80 years; ECOG 0-1.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Disease-Free Survival (DFS)
Timeframe: up to 60 months
2
Progression-Free Survival (PFS)
Timeframe: up to 36 months
3
Overall Survival (OS)
Timeframe: up to 60 months
Trial details
NCT IDNCT07152535
SponsorPeking University Cancer Hospital & Institute