Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

Phase 3

Recruiting

• Conditions: Esophageal Squamous Cell Cancer

• Registration Number: NCT06596954
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-11
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
acute grade 3/4 lymphopenia	1 months after surgery	from treatment to 1 months after completion of neoadjuvant chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group	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)
Incidence of grade 3 or higher hematologic toxicity	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.
Pathological complete response rate (pCR)	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.
R0 resection rate	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.
Postoperative complications	1 month after surgery	which was defined as 30-day postoperative complications graded according to the Clavien-Dindo classification;
recurrence-free survival	2 year	from completion of surgery to any recurrence
Overall survival	3 years	from treatment to death

Trial Locations

Locations (1)

Ruijin hospital, Shanghai jiaotong university school of medicine; 🇨🇳 Shanghai, China