The Study on the Mechanism of Radiotherapy-elicited Immune Response

NCT ID: NCT06393140

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-07-31

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.

Conditions

Esophageal Carcinoma Salivary Gland Type; Radiotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. new diagnosis locoregional esophageal cancer;

2. pathologic diagnosis is squamous carcinoma;

3. Patients had received either neoadjuvant or definitive radiotherapy

4. tumor and lymph node tissue can be collected and can be conducted with single cell RNA (scRNA)-sequencing and other sequencings.

Exclusion Criteria

1. Pregnant or lactating women.

2. Unable or rejection to receive radiotherapy or unable to comply with study requirements or follow-up schedule.

3. Inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Kuai Le Zhao, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuaile Zhao, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

Fudan University Shanghai cancer center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Kuaile Zhao

Role: CONTACT

kuaile_z@sina.com

86-18017312534

Facility Contacts

Kuaile Zhao

Role: primary

kuaile_z@sina.com

86-18017312534

Other Identifiers

ESO-shanghai 23

Identifier Type: -

Identifier Source: org_study_id