Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Esophageal Squamous Cell Cancer

Treatments: Radiation: conventional radiotherapy; Radiation: lymphocyte-sparing radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06596954

2024-210

Details and patient eligibility

About

Esophageal squamous cell carcinoma (ESCC) is one of the most aggressive malignant tumors. Although neoadjuvant chemoradiotherapy combined with surgery has significantly improved the survival rate of patients with locally advanced esophageal cancer, approximately half of the patients will experience local regional recurrence or distant metastasis. Lymphocytes are crucial immune cells in the human body, playing a key role in combating infections and tumor development. In recent years, an increasing body of research has indicated that lymphocyte depletion is a significant factor associated with poor prognosis in various solid tumors, including esophageal cancer. The lymphocyte depletion caused by radiotherapy has garnered considerable attention from oncologists. However, there is still a lack of prospective clinical research data on lymphocyte protection in thoracic tumors. Therefore, this study aims to provide high-level evidence from evidence-based medicine regarding the correlation between lymphocyte depletion and prognosis in esophageal cancer patients, offering more effective strategies and methods to improve the outcomes of neoadjuvant chemoradiotherapy for esophageal cancer.

Enrollment: 212 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients approve and sign written informed consent;
2. Pathologically confirmed esophageal squamous cell carcinoma;
3. the age of patients should be more than 18 years, and less than 80 years;
4. KPS score of patients should be more than 80

Exclusion criteria

1. diagnosis of metastatic esophageal cancer;
2. Patient refuses to receive systemic drug treatment;
3. clinical diagnosis of pleural metastasis or malignant pleural effusion;
4. Pregnant or breastfeeding women;
5. Severe non-cancerous medical comorbidities that affect the implementation of radiotherapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

lymphocyte-sparing radiotherapy

Experimental group

Description:

Firstly, ensure coverage of the PTV (Planning Target Volume). Secondly, limit the doses to the heart, bilateral lungs, and spinal cord to meet the required dose constraints. While maintaining target coverage and traditional OAR (Organs At Risk) dose constraints, also address dose limits for the TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels to protect the lymphocyte

Treatment:

Radiation: lymphocyte-sparing radiotherapy

conventional radiotherapy

Active Comparator group

Description:

ensure coverage of the PTV (Planning Target Volume) and limit the doses to the heart, bilateral lungs, and spinal cord to meet the required dose constraints. do not limits the dose for lymphocyte-related organs

Treatment:

Radiation: conventional radiotherapy