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NCT Number: NCT06393140

The Study on the Mechanism of Radiotherapy-elicited Immune Response

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Kuaile Zhao

CONTACT

[email protected]

86-18017312534

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 1, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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