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AI biomarker may reveal who responds to esophageal cancer immunotherapy

NCT ID NCT07745322

Diagnosis Sponsor: Peking University Cancer Hospital & Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial tests whether a new AI-driven biomarker, called the Microbial-Sensory Coupling (MSC) index, can predict how well patients with esophageal squamous cell carcinoma respond to anti-PD-1 immunotherapy. The biomarker measures the spatial relationship between a specific bacterium inside tumors and certain host cells. Researchers will analyze pre-treatment tumor biopsies from 270 patients to see if the MSC index can distinguish responders from non-responders and predict survival outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MSC index (a digital pathology biomarker measuring spatial proximity between Campylobacter gracilis and TAAR1+ tumor cells)
What this could lead to
If validated, this biomarker could help doctors predict which esophageal cancer patients will benefit from immunotherapy, sparing others from unnecessary side effects.
What could go wrong
The trial is early and the biomarker is experimental. It may not accurately predict responses in all patients, and the results may not generalize beyond this specific cancer type.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Esophageal Neoplasms esophageal squamous cell carcinoma neoplasm of esophagus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal neoplasms Esophageal squamous cell carcinoma

Contacts and locations

Locations

  • Peking University Cancer Hospital & Institute

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.