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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01963702
Eligibility Criteria:
Inclusion Criteria:
* Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months
* Patient must have at least one measurable lesions (RECIST 1.1)
* 18 Years to 75 years
* Written informed consent obtained
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must have adequate organ and marrow function as defined below:
* neutrophilicgranulocyte greater than/equal to 1,500/mm3;
* platelets greater than/equal to 90,000/ mm3;
* hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
* total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
* Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
* serum creatinine less than/equal to 1.5 x IULN.
Exclusion Criteria:
* Active clinically serious infections (\> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)
* Symptomatic metastatic brain or meningeal tumors
* History of organ allograft
* Patients undergoing renal dialysis
* chronic inflammatory bowel disease; ileus; genetic fructose intolerance
* Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
* Receive previously radiotherapy in measurable regions
* Pregnancy or lactating status
* Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
* Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
* Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
* Any factors that influence the usage of oral administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01963702
Study Brief:
Protocol Section:
NCT01963702