Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

NCT ID: NCT06596954

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2027-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

QIWEIXIANG

Deputy Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, China, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei-Xiang Qi, Dr.

Role: CONTACT

qwx12055@rjh.com.cn

+8602164370045

Facility Contacts

Wei-Xiang Qi, Dr.

Role: primary

qwx12055@rjh.com.cn

02164370045

References

Qi WX, Li S, Li H, Zhang S, Cai G, Xu C, Zhang Y, Chen J, Zhao S. Sparing lymphocytes during preoperative adjuvant radiotherapy for oesophageal squamous cell carcinoma (SPARE): protocol for an open-label, randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e096803. doi: 10.1136/bmjopen-2024-096803.

Reference Type: DERIVED

PMID: 40976677 (View on PubMed)

Other Identifiers

2024-210

Identifier Type: -

Identifier Source: org_study_id