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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04513418
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed esophageal cancer
* Staging as cT2N0M0 with high-risk lesions (lymphovascular invasion, ≥3cm, poorly differentiated) / cT1b-2N+M0 / cT3-4aN0-3M0 with the need of neoadjuvant therapy before radical esophagectomy
* Tolerance with oral intake (at least fluid diet)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Body Mass Index (BMI) ≥ 18.5 kg/m2 before recruitment
* Patient's approval and written informed consent
Exclusion Criteria:
* Expected survival time less than 6 months
* Complete dysphagia
* Pregnant or breast-feeding women
* Unable to obey the interventions because of any reasons
* Serious co-morbidities (cardiac, pulmonary, liver, kidney, brain, hematologic, endocrine and other diseases) in patients who cannot tolerate neoadjuvant therapy and/or surgery
* History of previous thoracic or abdominal surgery
* History of other malignant tumor (previous or current)
* Patients with primary small cell carcinoma of the esophagus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04513418
Study Brief:
Protocol Section:
NCT04513418