NCT07745322Active, not recruiting
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 · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 270 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 20 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07745322
What you commit to
- Study type: Observational
- Planned participants: 270
- From 20 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active autoimmune diseases or psychiatric disorders that prevent compliance.
Other
- Histology other than squamous cell carcinoma (e.g., adenocarcinoma, small cell carcinoma).
- Insufficient tumor tissue specimen for dual ISH-IF spatial analysis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital & Institute Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.