Clinical trial · Observational
Spatial MSC Index for Predicting Anti-PD-1 Efficacy in Esophageal Cancer
Clinical Validation of the Microbial-Sensory Coupling (MSC) Index as a Predictive Biomarker for Anti-PD-1 Immunotherapy Responsiveness in Esophageal Squamous Cell Carcinoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Discovery Cohort (Model Development, Retrospective)
- description
- 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.
- label
- Validation Cohort (Independent, Retrospective)
- description
- 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.
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 12 months from the first dose of anti-PD-1 therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available