Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

August 10, 2026 updated by: QIWEIXIANG, Ruijin Hospital

Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • China
      • Shanghai, China, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
        • Contact:
        • Principal Investigator:
          • shengguang zhao, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients are able to understand and are willing to participate in the trial, and a signed consent form can be obtained;
  2. Pathologically confirmed esophageal squamous cell carcinoma;
  3. locally advanced ESCC (cT3-4 or N+);
  4. the age of patients should be more than 18 years, and less than 80 years;
  5. aged between 18 and 80 years;
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lymphocyte-sparing radiotherapy
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
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.
Active Comparator: conventional radiotherapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute grade 3/4 lymphopenia
Time Frame: 1 months after surgery
from treatment to 1 months after completion of neoadjuvant chemoradiotherapy
1 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
from treatment to death
3 years
recurrence-free survival
Time Frame: 2 year
from completion of surgery to any recurrence
2 year
Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group
Time Frame: within 1 week after completion of neoadjuvat radiotherapy plan;
the pass rate of the esophageal cancer lymphocyte-sparing plan is evaluated without compromising target volume coverage and conventional normal tissue constraints (heart, lungs, and spinal cord)
within 1 week after completion of neoadjuvat radiotherapy plan;
Incidence of grade 3 or higher hematologic toxicity
Time Frame: from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy
The incidence of grade 3 or higher hematologic toxicity during nCRT and within 1 month after treatment between lymphocyte-sparing RT group and conventional RT group.
from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy
Pathological complete response rate (pCR)
Time Frame: 1 months after surgery
The pCR rate in ESCC patients who underwent nCRT and radical surgery between lymphocyte-sparing RT group and conventional RT group.
1 months after surgery
R0 resection rate
Time Frame: 1 month after surgery
the R0 resection rate in ESCC patients who underwent nCRT and radical surgery between lymphocyte-sparing RT group and conventional RT group.
1 month after surgery
Postoperative complications
Time Frame: 1 month after surgery
which was defined as 30-day postoperative complications graded according to the Clavien-Dindo classification;
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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