Lymphocyte-sparing radiotherapy for esophageal cancer
Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial
This study is testing a new type of radiation therapy for people with advanced esophageal cancer to see if it can protect their immune cells and improve their chances of survival.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, China) |
| Trial ID | NCT06596954 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel approach to treating esophageal squamous cell carcinoma (ESCC) by utilizing lymphocyte-sparing radiotherapy, which aims to minimize the depletion of immune cells during treatment. The research focuses on patients with locally advanced ESCC who are undergoing neoadjuvant treatment. By comparing the effects of lymphocyte-sparing radiotherapy to conventional radiotherapy, the study seeks to provide evidence on the potential benefits of preserving lymphocyte levels for improved patient outcomes. The goal is to enhance survival rates and reduce the risk of recurrence or metastasis in affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with pathologically confirmed esophageal squamous cell carcinoma and a KPS score greater than 80.
Not a fit: Patients with metastatic esophageal cancer or severe non-cancerous medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced recurrence in patients with esophageal cancer.
How similar studies have performed: While there is growing interest in lymphocyte-sparing approaches, this specific methodology has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, China
- Ruijin hospital, Shanghai jiaotong university school of medicine — Shanghai, China, China (Recruiting)
Study contacts
- Study coordinator: Wei-Xiang Qi, Dr.
- Email: qwx12055@rjh.com.cn
- Phone: +8602164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.