Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients: A Prospective Observational Study ("EXO-PPP Study")
Subjects eligible for enrollment must meet all of the following criteria:
1. Provide signed informed consent. The subject is capable of understanding and
complying with parameters as outlined in the protocol and able to sign informed
consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board
(IRB) prior to the initiation of any study-specific procedures
2. Men or women aged >= 18 years.
3. Eastern Cooperative Oncology Group Performance Status (ECOG) <= 2.
4. Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or
5. Metastatic disease or locally advanced disease not amenable to curative surgery.
6. Radiographically assessable, non-measurable disease or measurable disease as per
7. Life expectancy of at least 12 weeks from the time of enrollment.
8. No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix.
9. No prior chemotherapy for advanced disease.
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Gastric carcinoid, sarcomas, or squamous cell cancer.
2. Pregnant or lactating females.
3. Significant neurological or psychiatric disorders (psychotic disorders, dementia or
seizures) that would prohibit the understanding and giving of informed consent.
4. Active Hepatitis B or C or history of an HIV infection.
5. Active uncontrolled infection.