Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-interventional cohort follows patients with locally advanced esophageal squamous cell carcinoma who receive radiotherapy in combination with immunotherapy in routine practice. Researchers will record actual radiotherapy planning decisions, including margins around the tumor and regional lymph node coverage, without assigning a treatment. The study will compare 2-year locoregional recurrence-free survival and other outcomes such as overall survival, toxicity, lymphocyte changes, and completion of immunotherapy across different target-volume strategies. Additional analyses will explore how clinical and biological factors relate to treatment patterns and outcomes. The goal is to identify radiotherapy approaches that may achieve effective tumor control while minimizing harm.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 80 years, regardless of sex.
2. Histologically confirmed esophageal squamous cell carcinoma.
3. Clinical stage cT2-4aN0-3M0, or considered by a multidisciplinary team to be suitable for definitive immunotherapy combined with radiotherapy or preoperative immunotherapy combined with radiotherapy.
4. Planned to receive one of the following modern precision radiotherapy techniques: IMRT, VMAT, TOMO, proton therapy, or heavy-ion radiotherapy.
5. Contrast-enhanced CT completed before radiotherapy; endoscopy, EUS, PET/CT, or MRI is recommended when clinically appropriate to assist target volume delineation.
6. ECOG performance status of 0-2.
7. Expected survival of at least 6 months.
8. Able to understand the study and provide written informed consent.

Exclusion Criteria:

1. Presence of distant metastasis or malignant pleural or peritoneal effusion.
2. Previous thoracic radiotherapy that may affect the current target volume design or dose constraints.
3. Pre-existing esophagotracheal fistula, esophagoaortic fistula, or a high risk of perforation considered unsuitable for radiotherapy.
4. Active interstitial lung disease, severe infection, or uncontrolled autoimmune disease considered unsuitable for immunotherapy.
5. Severe missing data that prevent determination of the actual CTV margin, lymph node irradiation extent, or major study outcomes.
6. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

Where it's running

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.