The Study on the Mechanism of Radiotherapy-elicited Immune Response

Radiotherapy Clinical Trial

Official title:

The Study on the Mechanism of Radiotherapy-elicited Immune Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393140
• Other study ID #: ESO-shanghai 23
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: Fudan University
• Contact: Kuaile Zhao
• Phone: 86-18017312534
• Email: kuaile_z[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2026
• Est. primary completion date: July 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Radiotherapy

Locations

Country	Name	City	State
China	Fudan University Shanghai cancer center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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