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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT04764227
Eligibility Criteria:
Inclusion Criteria:
* Joined the study voluntarily and signed informed consent form;
* Age 18-75;
* ECOG 0-2;
* Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
* The operative incision healed well;
* T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
* No radiotherapy, chemotherapy or other treatments pre (post) surgery;
* PS ECOG 0-2;
* Life expectancy of more than 3 months;
* Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
* Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\< 1.5 x ULN;
* Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency;
* Use of an effective contraceptive for adults to prevent pregnancy.
Exclusion Criteria:
* Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
* Participation in other interventional clinical trials within 30 days;
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
* Drug addiction, Alcoholism or AIDS;
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
* Unsuitable to be enrolled in the trial in the opinion of the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04764227
Study Brief:
Protocol Section:
NCT04764227