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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05616533
Eligibility Criteria:
Inclusion Criteria:
1. patients aged 18-75years,
2. patients with gastric cancer confirmed by histology or cytology at first visit,
3. patients with advanced tumor by imaging evaluation,
4. patients with preoperative neoadjuvant therapy;
5. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
6. tolerance to chemotherapy in laboratory examination;
7. hematology examination: no obvious signs of hematological diseases, ANC ≥1.5 × 109/L before enrollment; Platelet count ≥80 × 109/L, HB ≥90 g/L, WBC ≥3.0 × 109/L, and no bleeding tendency;
8. biochemical examination: Total Bilirubin \<1.5 times of upper limit of normal value, AST, ALT \< 2.5 times of upper limit of normal value, creatinine \< 1.5 times of upper limit of normal value;
Exclusion Criteria:
1. patients with inoperable advanced gastric cancer,
2. patients with metastatic or primary gastric cancer,
3. pregnant or lactating women,
4. patients with a history of other malignancies in the last 5 years;
5. for those with a history of uncontrolled epilepsy, central nervous system disease or mental disorders, the severity of the clinical condition was assessed by the investigator as impeding the signing of informed consent or affecting the patient's compliance with oral medication;
6. clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or more heart failure, or arrhythmias requiring medical intervention; Or a history of myocardial infarction within the last 12 months;
7. severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc.
8. gastrointestinal obstruction or abnormal physiological function, or malabsorption syndrome, which may affect drug absorption;
9. gastrointestinal bleeding in the last two weeks or at high risk of bleeding as judged by the investigator;
10. patients with known peripheral nerve disease ≥ NCI-CTC AE Grade 1, but only with deep tendon reflexes (DTR) ;
11. organ transplantation requires immunosuppressive therapy;
12. the presence of any active, known or suspected autoimmune disease.
13. uncontrolled severe infection or other severe concomitant disease
14. hypersensitivity to paclitaxel, Oxaliplatin, 5-FU, or any clinically useful anti-gastric cancer agent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05616533
Study Brief:
Protocol Section:
NCT05616533