NCT07858630 Radiotherapy Target Volume Delineation in Locally Advanced Esophageal Cancer in the Immunotherapy Era
| NCT ID | NCT07858630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-08-23 |
| Primary Completion | 2034-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-08-23 with a primary completion date of 2034-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07858630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07858630 currently recruiting?
Yes, NCT07858630 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cancer Institute and Hospital, Chinese Academy of Medical Sciences to inquire about joining.
Where is the NCT07858630 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07858630 clinical trial?
NCT07858630 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 500 participants.