An observational study in Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, sponsored by Peking University Cancer Hospital & Institute. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Peking University Cancer Hospital & Institute · Observational
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.
Emerging evidence indicates that C. gracilis secretes a unique xenometabolite, cadaverine, which binds to and activates the host TAAR1 receptor on ESCC cells, thereby promoting tyrosine kinase FAK-dependent secretion of the chemokine and cytokine. This pathway orchestrates immune cells, leading to resistance to anti-PD-1 therapy.
This retrospective observational study employs multiplexed fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) / multiplex immunofluorescence (mIF), combined with deep-learning-based image segmentation, to quantify the spatial relationship between C. gracilis and TAAR1+ tumor cells.
The study consists of two phases:
646 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.
This study's planned enrollment of 270 is close to the median of 270 across 93 observational studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.
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Adult patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) who received standard anti-PD-1-based therapy (combined with chemotherapy or as monotherapy) at Beijing Cancer Hospital, retrospectively identified from institutional medical records and pathology archives. The study comprises two retrospective cohorts: a discovery cohort (n=120) used to construct the MSC index model, and an independent validation cohort (n=150) used to validate its predictive performance. Eligible cases are adults (aged 18 years and older) with ECOG performance status 0-1 at treatment initiation, at least one measurable lesion per RECIST 1.1 at baseline, adequate archived pre-treatment FFPE tumor tissue for dual ISH-IF spatial analysis, and complete follow-up data. Cases are included consecutively regardless of sex or ethnicity.
Exclusion Criteria:
This retrospective cohort includes 120 ESCC patients who received anti-PD-1-based therapy. Archived pre-treatment FFPE biopsy specimens are retrieved and used to establish the MSC index mathematical model via multiplexed FISH and mIF combined with deep-learning image segmentation. ROC analysis is applied to determine the optimal diagnostic cut-off value for predicting anti-PD-1 responsiveness.
This independent retrospective cohort includes 150 ESCC patients who received anti-PD-1-based therapy, identified from a non-overlapping case series. Archived pre-treatment FFPE biopsy specimens are used to validate the pre-determined MSC index cut-off value for its predictive specificity, sensitivity, and clinical utility in distinguishing immunotherapy responders from non-responders, as well as its association with PFS and OS.
Objective Response Rate (ORR)
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.
Time frame: Up to 12 months from the first dose of anti-PD-1 therapy
Diagnostic Accuracy (AUC)
Calculated using ROC analysis to evaluate the capability of the MSC index to discriminate between immunotherapy responders (CR/PR) and non-responders (SD/PD).
Time frame: Up to 12 months from the first dose of anti-PD-1 therapy (best overall response assessment)
Progression-Free Survival (PFS)
Time from the first dose of anti-PD-1 therapy to the date of objective disease progression or death from any cause, whichever occurs first.
Time frame: Up to 24 months
Overall Survival (OS)
Time from the first dose of anti-PD-1 therapy to the date of death from any cause.
Time frame: Up to 36 months
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Esophageal Squamous Cell Carcinoma→
Peking University Cancer Hospital & Institute