Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Registration Number
- NCT07152535
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 255
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-Free Survival (DFS) 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) up to 60 months time from study registration to death from any cause.
Progression-Free Survival (PFS) up to 36 months advanced cohort;time from start of first-line therapy to first documented disease progression per RECIST 1.1 or death.
- Secondary Outcome Measures
Name Time Method Time to Response (TTR) up to 60 months time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.
Objective Response Rate (ORR) best overall response up to 24 months; proportion with CR/PR by RECIST 1.1. up to 24 months
Biomarker Analyses baseline to 36-60 months exploratory associations for PD-L1, HER2, EGFR, ctDNA dynamics, IL-6/IL-8 and other immune/microbiome markers with outcomes.
Disease Control Rate (DCR) up to 24 months; proportion with CR/PR/SD by RECIST 1.1. up to 24 months