Esophageal Squamous Cell CancerNCT06596954
Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma
A study testing lymphocyte-sparing radiotherapy and conventional radiotherapy in people with Esophageal Squamous Cell Cancer, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Cancer
- What is being tested?
- lymphocyte-sparing radiotherapy and conventional radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital, Shanghai jiaotong university school of medicine
Shanghai, China, 200025
Wei-Xiang Qi, Dr., 02164370045, qwx12055@rjh.com.cn
shengguang zhao, Dr.
About this study
Official title: Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial
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
- Being tested
- lymphocyte-sparing radiotherapy, conventional radiotherapy
- Keywords
- esophageal cancer, neoadjuvant treatment, lymphocyte-sparing radiotherapy, prognosis
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphocyte-sparing radiotherapyRadiation
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 radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute grade 3/4 lymphopenia
from treatment to 1 months after completion of neoadjuvant chemoradiotherapy
Measured: 1 months after surgery
Secondary outcomes (7)
Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group
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)
Measured: within 1 week after completion of neoadjuvat radiotherapy plan;
Incidence of grade 3 or higher hematologic toxicity
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.
Measured: from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy
Pathological complete response rate (pCR)
The pCR rate in ESCC patients who underwent nCRT and radical surgery between lymphocyte-sparing RT group and conventional RT group.
Measured: 1 months after surgery
R0 resection rate
the R0 resection rate in ESCC patients who underwent nCRT and radical surgery between lymphocyte-sparing RT group and conventional RT group.
Measured: 1 month after surgery
Postoperative complications
which was defined as 30-day postoperative complications graded according to the Clavien-Dindo classification;
Measured: 1 month after surgery
recurrence-free survival
from completion of surgery to any recurrence
Measured: 2 year
Overall survival
from treatment to death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Jun 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QIWEIXIANG, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596954
- Sponsor's protocol ID
- 2024-210
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40976677
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06596954
- Acronym / sponsor ID
- 2024-210
- Conditions
- Esophageal Squamous Cell Cancer
- Keywords
- esophageal cancer, neoadjuvant treatment, lymphocyte-sparing radiotherapy, prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphocyte-sparing radiotherapythe 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. | Radiation | – |
| conventional radiotherapythe 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. | Radiation | – |
Primary outcome
acute grade 3/4 lymphopenia
Time frame: 1 months after surgery
from treatment to 1 months after completion of neoadjuvant chemoradiotherapy
7 secondary outcomes
Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group
Time frame: within 1 week after completion of neoadjuvat radiotherapy plan;
Incidence of grade 3 or higher hematologic toxicity
Time frame: from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy
Pathological complete response rate (pCR)
Time frame: 1 months after surgery
R0 resection rate
Time frame: 1 month after surgery
Postoperative complications
Time frame: 1 month after surgery
recurrence-free survival
Time frame: 2 year
Overall survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 40976677Qi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphocyte-sparing radiotherapy and conventional radiotherapy in people with Esophageal Squamous Cell Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Xiang Qi, Dr. (+8602164370045, qwx12055@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute grade 3/4 lymphopenia (time frame: 1 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06596954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.