Clinical trial · Interventional
Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma
Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Cancer | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional radiotherapy | Radiation | — | UNRESOLVED |
| lymphocyte-sparing radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- lymphocyte-sparing radiotherapy
- description
- 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
- type
- ACTIVE_COMPARATOR
- label
- conventional radiotherapy
- description
- 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
Primary outcomes (1)
- measure
- acute grade 3/4 lymphopenia
- timeFrame
- 1 months after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDQi 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