Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Keywords
ESCC, Multi-omics, ctDNA, Immunotherapy, Neoadjuvant Therapy, Prospective Cohort, Biomarkers
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.
Interventions
None listed
Sponsors
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Overall Survival (OS) | up to 60 months | time from study registration to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Objective Response Rate (ORR) | best overall response up to 24 months; proportion with CR/PR by RECIST 1.1. | up to 24 months |
| Disease Control Rate (DCR) | up to 24 months; proportion with CR/PR/SD by RECIST 1.1. | up to 24 months |
Contacts
Primary ContactZhihao Lu
Outcome results
None listed