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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03137004
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-75 years old;
2. Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
3. The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease.
4. Relapse within 6 months after adjuvant chemotherapy;
5. ECOG (Eastern Cooperative Oncology Group)performance status 0-2;
6. At least 1 measurable lesion should be present（RECIST1.1）
7. Available Organ function: Neutrophils\>2g/L, Hemoglobin\>9g/L, Blood platelet \>100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)\<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)\<1.0 ULN; Cr \<1.0ULN
8. Signed informed consent.
9. Life expectancy ≥3 months;
Exclusion Criteria:
1. Previous treatment with taxanes (not including intraperitoneal use of taxanes);
2. Known history of hypersensitivity to study drugs;
3. Active CNS metastases not controllable with radiotherapy or corticosteroids;
4. Pregnant or breast feeding women;
5. Severe co-morbid illness and/or active infections;
6. Active and uncontrollable bleeding from gastrointestinal tract
7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol;
8. Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
9. Known HIV infecton.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03137004
Study Brief:
Protocol Section:
NCT03137004