The Study on the Mechanism of Radiotherapy-elicited Immune Response

NCT06393140 | Recruiting

• 1 other identifier: ESO-shanghai 23
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma Salivary Gland Type; Radiotherapy

Keywords

Esophageal Carcinoma; Tumor-draining lymph nodes; Radiotherapy

Outcome Measures

Primary Outcomes (1)

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

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

  4-year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal cancer treated with radiotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai cancer center

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Histological specimens of tumors derived from surgical or metastatic sites

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Kuaile Zhao, MD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Kuaile Zhao

CONTACT

86-18017312534; kuaile_z@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 1, 2024
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

CN (1)