Clinical trial · Observational
Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Peri-operative ESCC Cohort
- description
- Patients with histologically confirmed ESCC who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy. Study assigns no treatment; care is per treating physicians. Study procedures include collection of tumor tissue/surgical specimens or archived FFPE slides and serial blood for ctDNA/cytokines, plus prospective follow-up of clinical outcomes.
- label
- Advanced ESCC First-line Immunotherapy Cohort
- description
- Patients with unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy at participating centers. No assigned intervention by the study; all treatments are per routine practice. Study procedures include tumor biopsy or archived FFPE slides and serial blood for ctDNA/cytokines, with prospective follow-up for responses and survival.
Primary outcomes (3)
- measure
- Disease-Free Survival (DFS)
- timeFrame
- up to 60 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: Peri-operative cohort: 1. Age ≥18 and \<80 years; ECOG 0-1. 2. Histologically confirmed ESCC. 3. 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: 1. Age ≥18 and \<80 years; ECOG 0-1. 2. Histologically confirmed ESCC, or highly suspected by endoscopy/imaging when surgery is not feasible. 3. No prior systemic anti-cancer therapy for advanced disease; archived FFPE slides (3-5 µm, 5-8 slides) acceptable if fresh tissue unavailable. 4. Able to provide clinical information and comply with follow-up. Exclusion Criteria: 1. Prior anti-cancer therapy (except standard neoadjuvant therapy in the peri-operative cohort). 2. Other malignancy within 5 years (exceptions: non-melanoma skin cancer, in-situ melanoma, in-situ cervical cancer). 3. Inadequate clinical information. 4. Known infection with HIV, HBV, HCV, or syphilis. 5. Pre-operative imaging indicates insufficient tumor tissue (no visible target region) for study procedures. 6. Any condition deemed by investigators to make the patient unsuitable.
References
Publications (0)
Data not yet available