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NCT Number: NCT06596954

Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, China, 200025

Location status: Recruiting

Location contact

Wei-Xiang Qi, Dr.

CONTACT

[email protected]

02164370045

shengguang zhao, Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. acute grade 3/4 lymphopenia

    Time frame: 1 months after surgery

    from treatment to 1 months after completion of neoadjuvant chemoradiotherapy

Secondary outcomes

  1. Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group

    Time frame: 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)

  2. Incidence of grade 3 or higher hematologic toxicity

    Time frame: 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.

  3. Pathological complete response rate (pCR)

    Time frame: 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.

  4. R0 resection rate

    Time frame: 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.

  5. Postoperative complications

    Time frame: 1 month after surgery

    which was defined as 30-day postoperative complications graded according to the Clavien-Dindo classification;

  6. recurrence-free survival

    Time frame: 2 year

    from completion of surgery to any recurrence

  7. Overall survival

    Time frame: 3 years

    from treatment to death

Study contacts

Contact information is provided by the study sponsor or research team.

Wei-Xiang Qi, Dr.

CONTACT

[email protected]

+8602164370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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