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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT04207918
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years
* Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
* Primary treatment accepted in Chinese Academy of Medical Sciences
* KPS ≥70
* NRS score ≥2
* Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma
* Normal organ and marrow function as defined below:
Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit
* Informed consent
Exclusion Criteria:
* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
* Any prior chemotherapy or other cancer treatment prior to this protocol
* With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
* History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
* Existing esophageal fistula, perforation and cachexia
* Existing active infection such as active tuberculosis and hepatitis
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* Participation in other clinical trials currently or within 4 weeks of selection
* Pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04207918
Study Brief:
Protocol Section:
NCT04207918