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:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT04936750
Eligibility Criteria:
Inclusion Criteria:
* Voluntary participation and face to face signed informed consent;
* 18 -- 75 years old, gender unlimited;
* The histological diagnosis was esophageal squamous cell carcinoma, and the clinical staging was stage II-IVA (according to AJCC stage 8, pre-treatment clinical staging was: CT1N2-3M0, CT2-4BN0-3M0).
* Initial treatment patients receiving radical concurrent chemoradiotherapy; Immunotherapy with or without combination;
* The primary tumor can be evaluated;
* No distant metastasis;
* No serious abnormal function of blood system, heart, lung, liver and kidney or immune deficiency;
* Hemoglobin (Hb) ≥9 g/dL; White blood cell (WBC) ≥3×109/L; Neutrophils (ANC)≥1.5×109/L; Platelet (PT)≥100×109/L;
* Bilirubin \< 1.5 times the upper limit of normal; Alanine aminotransferase (ALT) and alanine aminotransferase (AST) ≤2.5 times the upper limit of normal;
* Serum creatinine ≤1.5 times the upper limit of normal value;
* The willingness of men or women of reproductive age to use contraception in the trial;
* Physical condition score ECOG 0 \~ 2;
* The expected survival time was \>3 months.
Exclusion Criteria:
* Patients who lacked an evaluation of CT body composition within 15 days prior to treatment initiation;
* Patients with severe intestinal function damage or inability to tolerate intestinal nutrition;
* The digestive tract is severely obstructed, unable to take food orally and unable/unwilling to undergo nasogastric tube or percutaneous gastrostomy;
* Previous surgery, chemoradiotherapy or bio-targeted therapy for esophageal cancer;
* Previous history of malignant tumor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04936750
Study Brief:
Protocol Section:
NCT04936750