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

NCT07152535 | Not Yet Recruiting DMC

• 2 other identifiers: PKU-ESCC-0604LGH2025236
• Study Type: observational
• Target: 255
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

ESCC; Multi-omics; ctDNA; Immunotherapy; Neoadjuvant Therapy; Prospective Cohort; Biomarkers

Outcome Measures

Primary Outcomes (3)

• Disease-Free Survival (DFS)

  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.

  up to 60 months

• Progression-Free Survival (PFS)

  advanced cohort;time from start of first-line therapy to first documented disease progression per RECIST 1.1 or death.

  up to 36 months

• Overall Survival (OS)

  time from study registration to death from any cause.

  up to 60 months

Secondary Outcomes (4)

• Time to Response (TTR)

  up to 60 months

• Objective Response Rate (ORR)

  best overall response up to 24 months; proportion with CR/PR by RECIST 1.1.

• Disease Control Rate (DCR)

  up to 24 months; proportion with CR/PR/SD by RECIST 1.1.

• Biomarker Analyses

  baseline to 36-60 months

Study Arms (2)

Peri-operative ESCC Cohort

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

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.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18-79 years) with histologically confirmed esophageal squamous cell carcinoma (ESCC) treated at Peking University Cancer Hospital and participating centers in China. Two prospective cohorts: (1) peri-operative patients who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy; (2) unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy. ECOG 0-1. Tumor tissue (biopsy or surgical; archived FFPE slides acceptable if fresh tissue is unavailable) and serial blood are collected for multi-omics analyses. Key exclusions include prior systemic therapy for advanced disease (except neoadjuvant in the peri-operative cohort), other active malignancies within 5 years (allowing non-melanoma skin and in-situ cervical cancer), inadequate clinical information, or investigator-assessed unsuitability.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biopsy before neoadjuvant/first-line therapy; surgical specimens and adjacent tissue from transthoracic esophagectomy; archived FFPE slides (3-5 μm, 5-8 slides when fresh tissue is unavailable); serial blood for ctDNA and cytokines (e.g., IL-6/IL-8). All specimens are obtained from routine clinical care with consent and retained for DNA analyses.

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Zhihao Lu

CONTACT

+85201088196561; pppeirain@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08