Clinical trial NCT06393140: The Study on the Mechanism of Radiotherapy-elicited Immune Response
Official title: The Study on the Mechanism of Radiotherapy-elicited Immune Response
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Carcinoma Salivary Gland Type
Radiotherapy
Keywords: Esophageal Carcinoma
Tumor-draining lymph nodes
Radiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal cancer treated with radiotherapy

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.

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.

Primary outcomes:
measure: Genetic signature of patients who had received neoadjuvant or definitive radiation therapy
timeFrame: 4-year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai cancer center
Study officials:
affiliation: Fudan University
name: Kuaile Zhao, MD
role: STUDY_DIRECTOR
References: