Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

NCT06596954 | Recruiting

• 1 other identifier: 2024-210
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Keywords

esophageal cancer; neoadjuvant treatment; lymphocyte-sparing radiotherapy; prognosis

Outcome Measures

Primary Outcomes (1)

• acute grade 3/4 lymphopenia

  from treatment to 1 months after completion of neoadjuvant chemoradiotherapy

  1 months after surgery

Secondary Outcomes (7)

• Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group

  within 1 week after completion of neoadjuvat radiotherapy plan;

• Incidence of grade 3 or higher hematologic toxicity

  from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy

• Pathological complete response rate (pCR)

  1 months after surgery

• R0 resection rate

  1 month after surgery

• Postoperative complications

  1 month after surgery

Study Arms (2)

lymphocyte-sparing radiotherapy

EXPERIMENTAL

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

conventional radiotherapy

ACTIVE COMPARATOR

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

Interventions

lymphocyte-sparing radiotherapy RADIATION

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.

conventional radiotherapy RADIATION

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, China, 200025, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40976677 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Wei-Xiang Qi, Dr.

CONTACT

+8602164370045; qwx12055@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 11, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)