Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
NCT ID: NCT07152535
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
255 participants
OBSERVATIONAL
2025-09-01
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
79 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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LGH2025236
Identifier Type: OTHER
Identifier Source: secondary_id
PKU-ESCC-0604
Identifier Type: -
Identifier Source: org_study_id
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