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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05001360
Eligibility Criteria:
Inclusion Criteria:
* Voluntarily participate in this study and provide written informed consent
* Age ≥ 18 years and ≤70 years, male or female
* Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies
* Able and willing to provide tumor tissue
* At least one measurable extracranial target lesion according to iRECIST
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy ≥3 months
Exclusion Criteria:
* History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin
* Had systemic diseases that were difficult to control within 4 weeks prior to screening
* History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy
* History of coagulation disorders
* Mechanical or paralytic obstruction of the gastrointestinal tract
* Anticipated to receive a great number of antibiotics during study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05001360
Study Brief:
Protocol Section:
NCT05001360