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Recruiting NCT06393140

The Study on the Mechanism of Radiotherapy-elicited Immune Response

Observational Esophageal Carcinoma Salivary Gland Type Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Esophageal Carcinoma Salivary Gland Type, Radiotherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. Data from many laboratories indicate that local radiation produces systemic, immune-mediated anti¬tumour and, potentially, antimetastatic effects. Additionally, the combination of local radiotherapy and immune-modulation can augment local tumour control and cause distant (abscopal) antitumour effects through increased tumour-antigen release and antigen-presenting cell (APC) cross-presentation, improved dendritic-cell (DC) function, and enhanced T cell priming. The generation of an effective antitumor immune response requires the presentation of tumor antigens to naïve CD8+ cells in tumor-draining lymph nodes (TDLN) . Tumor-draining lymph nodes, however, are often subject to the immunosuppressive activity of tumor-derived factors, such as cytokines and other bioactive molecules from tumor cells and their associated leukocytes in the primary tumor site that contribute to the overriding of effective rejection mechanisms. Thus, in TDLN a T cell tolerance rather than a T cell activation often occurs, thereby preventing immune attack and facilitating local tumor progression.

Detailed description

In this study, the investigators collect clinical and biological evidence to interpret the impact of radiotherapy on tumor regression and immunity, and identify key molecular features and immune landscape patterns to characterize patients sensitive/resistant to radiotherapy; and define the dynamic changes occurring in TME and lymph node after radiotherapy.

Primary outcome measures

  • Genetic signature of patients who had received neoadjuvant or definitive radiation therapy [Time frame: 4-year]

Eligibility criteria

Inclusion criteria

  • new diagnosis locoregional esophageal cancer;
  • pathologic diagnosis is squamous carcinoma;
  • Patients had received either neoadjuvant or definitive radiotherapy
  • tumor and lymph node tissue can be collected and can be conducted with single cell RNA (scRNA)-sequencing and other sequencings.

Exclusion criteria

  • Pregnant or lactating women.
  • Unable or rejection to receive radiotherapy or unable to comply with study requirements or follow-up schedule.
  • Inability to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fudan University Shanghai cancer center — Shanghai

Identifiers

NCT: NCT06393140 · ESO-shanghai 23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗