Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed inoperable or metastatic adenocarcinoma of the stomach or lower third of the oesophagus refractory or intolerable to standard therapy.
• Patients must have measurable or evaluable disease.
• Age >= 201years
• ECOG performance status of 0 to 2
• Life expectancy at least 3 months
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count >=1,500/mcL
• platelets >=100,000/mcL
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of
• Normal creatinine within normal institutional limits
• Patients must be HLA-A*2402
• Patients must have recover from all reversible treatment toxicity from prior chemotherapy, radiotherapy or surgery.
• The effects of OTSGC-A24 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients receiving any other investigational agents.
• History of significant gastrointestinal bleeding that required intervention within the prior 1 month is ineligible; inherited bleeding diathesis or coagulopathy.
• Serious non healing wound and peptic ulcer disease
• Previous history of intestinal perforation
• Invasive procedures defined as follows (Insertion of a vascular access device is not considered major/minor surgery):
• Major surgical procedure, open biopsy or significant traumatic injury =28 days prior to -registration
• Anticipation of need for major surgical procedures during the course of the study
• Core biopsy <=7 days
• Minor surgery <=2 weeks
• Symptomatic CNS metastasis
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction/cerebrovascular event (<=6 months prior to study entry), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, long term systemic immunosuppressant or corticosteroid.
• Women who are breast-feeding or pregnant are excluded from this study