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

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.

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.