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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT05593458
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group(ECOG) score 0-1
* Ambulatory males or females, aged 18-75 years
* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
* Locally advanced gastric carcinoma (cT3N2-3M0, cT4aN1-3M0, cT4bNanyM0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition)
* Life expectancy more than 3 months
* Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
* Normal hepatic, renal, and bone marrow function (ALT/AST\<2.5 fold of upper limit value;Tbil\<1.5mg/dl, Cr\<1.5 fold of upper limit value; White Blood Cell count≥3 × 10\^9/L, ANC ≥ 1.5 × 10\^9/L,PLT≥ 80 × 10\^9/L,Hb ≥ 90 g/L).
Exclusion Criteria:
* Patients can not bear surgical procedure.
* Pregnant or lactating women.
* HER2 overexpression(+++) confirmed by immunohistochemistry.
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
* 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.
* History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation;
* 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.
* With abdominal cavity implantation metastasis or distant metastasis.
* Unwilling or unable to comply with the protocol for the duration of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05593458
Study Brief:
Protocol Section:
NCT05593458