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Not yet recruiting NCT07152535

Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor

— Observational Esophageal Squamous Cell Carcinoma (ESCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma (ESCC). Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Primary outcome measures

  • Disease-Free Survival (DFS) [Time frame: up to 60 months]
  • Progression-Free Survival (PFS) [Time frame: up to 36 months]
  • Overall Survival (OS) [Time frame: up to 60 months]
Secondary outcome measures (4)
  • Time to Response (TTR) [Time frame: up to 60 months]
  • Objective Response Rate (ORR) [Time frame: best overall response up to 24 months; proportion with CR/PR by RECIST 1.1.]
  • Disease Control Rate (DCR) [Time frame: up to 24 months; proportion with CR/PR/SD by RECIST 1.1.]
  • Biomarker Analyses [Time frame: baseline to 36-60 months]

Eligibility criteria

Inclusion criteria

Peri-operative cohort:

  • 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.

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 0-1.
  • 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.
  • Any condition deemed by investigators to make the patient unsuitable.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07152535 · PKU-ESCC-0604 · LGH2025236

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗