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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT02999295
Eligibility Criteria:
Inclusion Criteria:
* Advanced or recurrent unresectable gastric or GEJ cancer
* Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
* Patients with normal oral intake
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients who have measurable target lesion
* Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
* Patients with adequate organ function
* Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
* Patients with written informed consent
Exclusion Criteria:
* Patients have double cancer
* Patients have infection required systemic therapy
* Known central vervous system (CNS) metastasis
* Patients with history of pneumonitis or pulmonary fibrosis
* Patients with history of serious anaphylaxis induced by antibody preparation
* Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease
* Female who is pregnant, lactating or suspected pregnancy
* Patients with psychosis or dementia to interfere to obtain informed consent appropriately
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02999295
Study Brief:
Protocol Section:
NCT02999295