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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05356520
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed EGJ type II adenocarcinoma
··The tumor can be removed by laparoscopy through the gastrodiaphragmatic esophageal hiatus or by endoscopic Ivor Lewis operation
* Pretreatment stage CT1-4A, N0-3, M0
* For cT4a stage patients, their resectable properties must be clearly verified before randomization
* For locally advanced tumors (CT3-T4 or N+), all 4 cycles of chemotherapy (FLOT) were completed before surgery.
* 18 to 75 years old
* ECOG score 0-2
* ASA \<4
* Good bone marrow function (leukocyte \> x 10 \^ 9 / l; Hemoglobin\> 9 g/dl. ·Platelet\>100×10\^9/ L), renal function (glomerular filtration rate \& GT; 60ml/min) and liver function (total bilirubin \< 1.5 times normal (ULN), aspartate aminotransferase (AST\< 2.5x ULN, Alanine aminotransferase (ALT)\<3 x ULN)
* Patients and their family members voluntarily sign written informed consent
Exclusion Criteria:
* Histologically confirmed EGJ type I and III adenocarcinoma
* Tumor spread over 5 cm proximal to EGJ
* Clinically significant (active) heart disease (i.e. symptomatic coronary artery disease or myocardial infarction within the last 12 months) resulting in left ventricular ejection fraction\<50%(determined by echocardiography)
* Clinically significant lung diseases (forced expiratory volume in 1 second (FEV1)\<1.5 l/s)
* Pregnant women and nursing mothers
* Stump gastric cancer
* Borrmann Type 4 (Leather stomach)
* Simultaneous or heterochronous malignant tumors of other organs except carcinoma in situ of the cervix and adenoma and focal colorectal carcinoma
* Right thoracotomy or history of right pleural adhesion
* Cirrhosis, or indocyanine green test ≥15% of chronic liver disease
* No seizure control, central nervous system diseases or mental disorders
* History of upper abdominal surgery (except laparoscopic cholecystectomy)
* The patient has coagulation dysfunction and cannot be corrected
* Patients with heart, lung, liver, brain, kidney and other important organ failure
* Patients with metabolic diseases such as diabetes
* Immunosuppressive therapy, such as organ transplantation, SLE, etc
* Seriously out of control recurrent infections or other seriously out of control concomitant diseases
* Other diseases requiring simultaneous surgery
* Diseases requiring emergency surgery due to tumor emergencies (e.g. hemorrhage, perforation, obstruction)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05356520
Study Brief:
Protocol Section:
NCT05356520