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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04486651
Eligibility Criteria:
Inclusion Criteria:
* Understood and signed an informed consent form.
* Age ≥ 18 and ≤ 75 years old, male or female.
* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
* Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
* Willing to provide tissue for PD-L1 biomarker analysis.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
* Life expectancy ≥ 3 months.
* Has adequate organ function.
* Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.
Exclusion Criteria:
* Has squamous cell or undifferentiated gastric cancer.
* Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
* Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
* Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has uncontrolled ascites, pleural effusion, or pericardial effusion.
* Has active autoimmune disease that has required systemic treatment in past 2 years.
* Has received a major surgery within 4 weeks prior to randomization.
* Has received system treatment with corticosteroids (dose \>10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
* Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.
* Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.
* Has any serious and/or uncontrolled disease.
* Has active viral infection.
* Has received a live vaccine within 30 days prior to the first dose of trial treatment.
* Has participated in other anticancer drug clinical trials within 4 weeks.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04486651
Study Brief:
Protocol Section:
NCT04486651