Spatial MSC Index for Predicting Anti-PD-1 Efficacy in Esophageal Cancer

Running, not enrolling

Conditions studied: Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

In brief

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.

Key facts

Study ID

NCT07745322

Run by

Peking University Cancer Hospital & Institute

People needed

270

Starts

2026-05-20

Expected to finish

2027-12-31

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed esophageal squamous cell carcinoma (ESCC).
• 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.
• Availability of adequate, high-quality archived pre-treatment tumor tissue biopsies (FFPE blocks or unstained slides) containing sufficient tumor and stromal areas.
• At least one measurable target lesion according to RECIST 1.1 criteria at baseline.
• ECOG performance status of 0 or 1 at the initiation of anti-PD-1 therapy.
• Complete clinicopathological and follow-up data retrievable from medical records.

You may not qualify if…

• Histology other than squamous cell carcinoma (e.g., adenocarcinoma, small cell carcinoma).
• Prior systemic exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immunotherapy agents.
• Concomitant systemic antibiotic, antifungal, or antiviral treatment within 14 days prior to tissue biopsy collection.
• Active autoimmune diseases or psychiatric disorders that prevent compliance.
• Insufficient tumor tissue specimen for dual ISH-IF spatial analysis.

Where it is running

• Peking University Cancer Hospital & Institute — Beijing, China

Full record on ClinicalTrials.gov

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