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

Peking University Cancer Hospital & Institute

Status: Not yet enrolling

Conditions: Esophageal Squamous Cell Carcinoma (ESCC)

Study type: Observational

Funder types: Other

Identifiers

NCT07152535

PKU-ESCC-0604

LGH2025236 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 255 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

255 participants in 2 patient groups

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.

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.