NCT07858630Recruiting
Radiotherapy Target Volume Delineation in Locally Advanced Esophageal Cancer in the Immunotherapy Era
A Prospective Cohort Study of Radiotherapy Target Volume Delineation Patterns in Locally Advanced Esophageal Cancer in the Immunotherapy Era
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
This prospective observational cohort study will evaluate different radiotherapy target volume delineation patterns in patients with locally advanced esophageal squamous cell carcinoma receiving radiotherapy combined with immunotherapy. In routine clinical practice, physicians may use different margins around the primary tumor and different approaches to regional lymph node irradiation. The study will not assign participants to a specific radiotherapy strategy. Instead, participants will receive treatment according to routine clinical practice, and the actual radiotherapy plans will be recorded and analyzed. The study will compare locoregional tumor control, recurrence patterns, survival, treatment-related toxicity, lymphocyte reduction, and completion of immunotherapy among patients receiving different target volume strategies. The main objective is to evaluate 2-year locoregional recurrence-free survival and to identify radiotherapy approaches that may achieve effective tumor control while reducing unnecessary radiation exposure and treatment-related toxicity.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- 23 Aug 2026
- Primary completion date
- 30 Jul 2034
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07858630
What you commit to
- Study type: Observational
- Planned participants: 500
- From 23 Aug 2026 to the primary completion date, 30 Jul 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous thoracic radiotherapy that may affect the current target volume design or dose constraints.
- Severe missing data that prevent determination of the actual CTV margin, lymph node irradiation extent, or major study outcomes.
Other illness
- Presence of distant metastasis or malignant pleural or peritoneal effusion.
- Pre-existing esophagotracheal fistula, esophagoaortic fistula, or a high risk of perforation considered unsuitable for radiotherapy.
- Active interstitial lung disease, severe infection, or uncontrolled autoimmune disease considered unsuitable for immunotherapy.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Who the study is looking for
- Age 18 to 80 years, regardless of sex.
- Histologically confirmed esophageal squamous cell carcinoma.
- 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.
- Planned to receive one of the following modern precision radiotherapy techniques: IMRT, VMAT, TOMO, proton therapy, or heavy-ion radiotherapy.
- Contrast-enhanced CT completed before radiotherapy; endoscopy, EUS, PET/CT, or MRI is recommended when clinically appropriate to assist target volume delineation.
- ECOG performance status of 0-2.
- Expected survival of at least 6 months.
- Able to understand the study and provide written informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.