The intratumoral microbiota is a key modulator of the tumor immune microenvironment. This study aims to clinically validate a novel, AI-driven digital pathology biomarker-the Microbial-Sensory Coupling (MSC) index-which measures the spatial proximity between the intratumoral bacterium Campylobacter gracilis(C. gracilis) and host Trace Amine-Associated Receptor 1 (TAAR1)+ tumor cells. The study will evaluate whether the MSC index, measured in pre-treatment tumor biopsy tissues, can accurately predict clinical responsiveness and survival outcomes in ESCC patients undergoing anti-PD-1-based immunotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Histologically confirmed esophageal squamous cell carcinoma (ESCC).
2. Received standard anti-PD-1 antibody therapy (e.g., pembrolizumab, camrelizumab, sintilimab, toripalimab) combined with chemotherapy or as monotherapy, with at least one post-treatment response evaluation available.
3. Availability of adequate, high-quality archived pre-treatment tumor tissue biopsies (FFPE blocks or unstained slides) containing sufficient tumor and stromal areas.
4. At least one measurable target lesion according to RECIST 1.1 criteria at baseline.
5. ECOG performance status of 0 or 1 at the initiation of anti-PD-1 therapy.
6. Complete clinicopathological and follow-up data retrievable from medical records.
Exclusion Criteria:
1. Histology other than squamous cell carcinoma (e.g., adenocarcinoma, small cell carcinoma).
2. Prior systemic exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immunotherapy agents.
3. Concomitant systemic antibiotic, antifungal, or antiviral treatment within 14 days prior to tissue biopsy collection.
4. Active autoimmune diseases or psychiatric disorders that prevent compliance.
5. Insufficient tumor tissue specimen for dual ISH-IF spatial analysis.
Primary outcome measure(s)
Objective Response Rate (ORR) — Up to 12 months from the first dose of anti-PD-1 therapy Percentage of patients achieving Complete Response (CR) or Partial Response (PR) based on RECIST 1.1 criteria, compared between MSC-high and MSC-low groups.
Trial sites (1)
Facility
City
Region
Status
Peking University Cancer Hospital & Institute
Beijing
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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