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 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT05812495
Eligibility Criteria:
Inclusion Criteria:
1. The clinical staging of pathological and imaging diagnosis was cT1b-4a, N0-2, M0 stage of lower thoracic esophageal squamous cell carcinoma or Siewert type I and Siewert type II esophageal gastric junction adenocarcinoma (8th UICC-TNM staging);
2. The lesion is potentially resectable;
3. CT3-4a and/or N+patients receive neoadjuvant therapy with the informed consent of patients and their families
4. Comprehensive evaluation is suitable for Ivor Lewis operation
5. Aged 18-75 years, both male and female;
6. There was no contraindication in the preoperative examination and evaluation of various organ functions;
7. The following laboratory tests confirmed that the bone marrow, liver and kidney functions and blood coagulation met the requirements for participating in the study:
Hemoglobin ≥ 9.0g/L;
White blood cell count ≥ 4.0 × 109/L；
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
Platelet count ≥ 100 × 109/L；
The international standardized ratio of prothrombin time ≤ 1.5 times the upper limit of normal value, and part of the thromboplastin time is within the range of normal value;
Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value or creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula);
Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
The level of AST or ALT ≤ 2.5 times the upper limit of normal value (ULN);
Urine protein\<2+; If the urine protein ≥ 2+, the 24-hour urine protein quantitative display must be ≤ 1g;
8. Lung function: FEV1 ≥ 1.2L, FEV1% ≥ 50% and DLCO ≥ 50%
9. Estimated lifetime ˃ 12 months.
10. R0 resection is expected;
11. The color Doppler ultrasound of the neck showed no suspicious metastatic lymph nodes;
12. Generally in good condition, individual machine energy meter (Karnofsky score, KPS) ≥ 70; Physical status ECOG 0-2 points;
13. The subjects were fully informed of the purpose of the study, voluntarily joined the study, with good compliance, safety and survival follow-up.
Exclusion Criteria:
1. Patients with cervical and upper middle thoracic esophageal cancer or Siewert III esophageal gastric junction cancer;
2. Patients with T4b stage inoperable, multiple lymph node enlargement (estimated metastasis ≥ 3), multistation lymph node enlargement (estimated lymph node metastasis ≥ 2) or distant metastasis (M1);
3. Those who can not use stomach to replace esophagus in this operation due to previous operation
4. Previous history of other malignant tumors;
5. Pathological examination of non squamous and non adenocarcinoma patients;
6. Preoperative neoadjuvant chemotherapy and radiotherapy;
7. Severe emphysema and pulmonary fibrosis;
8. Confirmed history of congestive heart failure; Angina pectoris with poorly controlled medication; Transmural myocardial infarction confirmed by electrocardiogram (ECG); Poor control of hypertension; Valvular heart disease with clinical significance; Or high risk uncontrollable arrhythmia;
9. Serious uncontrolled systemic diseases, such as active infection or poorly controlled diabetes;
10. Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\>2g/L), bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant treatment;
11. Those who already have or are associated with hemorrhagic diseases;
12. People with peripheral nervous system disorder or obvious mental disorder and central nervous system disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05812495
Study Brief:
Protocol Section:
NCT05812495