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Clinical Trials/NCT06393140
NCT06393140
Recruiting
Not Applicable

The Study on the Mechanism of Radiotherapy-elicited Immune Response

Fudan University1 site in 1 country200 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Carcinoma Salivary Gland Type
Sponsor
Fudan University
Enrollment
200
Locations
1
Primary Endpoint
Genetic signature of patients who had received neoadjuvant or definitive radiation therapy
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kuai Le Zhao, MD

professor

Fudan University

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.

Outcomes

Primary Outcomes

Genetic signature of patients who had received neoadjuvant or definitive radiation therapy

Time Frame: 4-year

Detailed mechanism of radiation-activated immunity under single-cell sequencing.gene mutations, copy number variants.

Study Sites (1)

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