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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT02949258
Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed gastric adenocarcinoma;
* males or females, aged 30-70 years;
* gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (without definitive ulceration) that invaded more than half of the stomach;
* no peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
* eastern Cooperative Oncology Group performance status of 0 or 1;
* no serious concomitant diseases that make survival period \< 3 years;
* no prior anti-tumor therapy;
* have signed informed consent before the beginning of treatment.
Exclusion Criteria:
* patients can not bear surgical procedure;
* pregnant or lactating women;
* previous cytotoxic chemotherapy, radiotherapy or immunotherapy;
* with peritoneal metastasis or distant metastasis;
* history of another malignancy within the last five years;
* history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake;
* clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months;
* organ allografts requiring immunosuppressive therapy;
* serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease;
* moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN);
* hypersensitivity to any drug of the study regimen;
* unwilling or unable to comply with the protocol for the duration of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT02949258
Study Brief:
Protocol Section:
NCT02949258