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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT01783951
Eligibility Criteria:
Inclusion Criteria:
* Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
* Between 18 and 80 years old
* Capable of oral intake
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Karnofsky Performance Status (KPS) ≥ 70%
* Normal functions of heart, lung and bone marrow
* Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
* Adequate renal function(normal serum creatinine level)
* A life expectancy≥ 2 months
* Informed consent signed
Exclusion Criteria:
* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
* Any radiotherapy or surgery within the previous 4 weeks
* Symptomatic brain metastasis not controlled by corticosteroids
* Bone marrow metastasis
* Active infection
* Serious complications
* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
* Ineligible for the study at the discretion of investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01783951
Study Brief:
Protocol Section:
NCT01783951