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 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT03801668
Eligibility Criteria:
Inclusion Criteria:
1. Age of 18-75 years;
2. Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
3. At least one measurable lesion as defined by RECIST 1.1 criteria;
4. ECOG performance status of 0-1;
5. Estimated life expectancy of at least 3 months;
6. Left ventricular ejection fraction (LVEF) ≥ 50%;
7. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
8. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;
9. Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
10. Able and willing to comply with the study plans in this protocol and sign the informed consent;
Exclusion Criteria:
1. Have received chemotherapy before；patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed\>6 months prior to first recurrence or metastasis;
2. HER-2 positive;
3. Patients with symptomatic brain metastases;
4. II-IV peripheral neuropathy \[NCI-CTCAE 4.03\];
5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
6. Patients with serious systemic infection or other diseases;
7. Allergic to the chemotherapy drugs or the materials in this study;
8. Patients with gastrointestinal bleeding that need clinical intervention;
9. Patients with digestive tract obstruction or oral nutrition difficulty;
10. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
11. Have participated in other clinical trials within 28 days prior to the first dose of this study;
12. Contraindications to chemotherapy;
13. Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03801668
Study Brief:
Protocol Section:
NCT03801668