Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

NCT06596954 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-08-11

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Squamous Cell Cancer

Interventions

RADIATION

lymphocyte-sparing radiotherapy

the radiotherapy regimen is 41.4Gy/23Fx. Ensure 95% 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. While maintaining target coverage and traditional OAR (Organs At Risk) dose constraints, also address dose for lymphocyte-relate organs including the TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels.

RADIATION

conventional radiotherapy

the radiotherapy regimen is 41.4Gy/23Fx. Ensure 95% 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 limit dose for lymphocyte-relate organs including the TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2027-06-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596954 on ClinicalTrials.gov