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:
NCT04115618
Eligibility Criteria:
Inclusion Criteria:
1. Histological or cytologic diagnosis of esophageal squamous carcinoma;
2. Aged 18-75 years;
3. KPS ≥ 70;
4. Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;
5. Stage I-IVA(AJCC 6th,2009);
6. Not able to be surgically resection or rejected;
7. Not have received any prior anticancer therapy;
8. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10\^9/L, platelet count ≥100x 10\^9/L, serum creatinine\<1.5 mg/dL,urea nitrogen \<8 mmol/L;
9. No history of malignancy;
10. No perforation of esophagus, no deep ulcer of esophagus;
11. Joined the study voluntarily and signed informed consent form.
Exclusion Criteria:
1. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
2. Patient who has metastasis such as lung, liver metastasis;
3. Other malignant tumors;
4. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
5. Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;
6. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;
7. Combination of pure red cell anemia or gamma globulin;
8. Allergic to any medication component studied.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04115618
Study Brief:
Protocol Section:
NCT04115618