Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT06603402
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years
* Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy), including:
Cervical esophagus involvement, T4 stage, supraclavicular lymph node metastasis, or inability to tolerate or refusal of surgery due to personal reasons; Failure of neoadjuvant or conversion therapy;Unresectable local recurrence after surgery (with measurable target lesions)
* No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
* Ability to provide fresh tumor tissue specimens (baseline)
* Normal function of major organs
* Performance Status (PS) score ≤ 1
* Patients of childbearing potential must agree to use contraception.
* Voluntary participation with signed informed consent
Exclusion Criteria:
* History of fistula formation due to primary tumor invasion
* High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
* Poor nutritional status
* Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
* Presence of symptoms or signs of interstitial disease
* Patients with any severe and/or uncontrolled medical condition
* Presence of concurrent malignancies
* Presence of other autoimmune diseases or long-term use of immunosuppressants or corticosteroids.
* Patients who are difficult to communicate with or are unlikely to comply with long-term follow-up.
* Any other conditions that the investigator deems unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06603402
Study Brief:
Protocol Section:
NCT06603402