gastric cancer
Conditions
Interventions
Intervention type:DRUG
Name of intervention:OTSGC-A24
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:SUBCUTANEOUS
Dose per administration:1
mL
Sponsors
Wakayama medical university Second department of surgery Hiroki Yamaue
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Patients must have measurable or evaluable disease. 3. Age >= 21 years 4. ECOG performance status of 0 to 2 5. Life expectancy at least 3 months 6. 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): <=2.5X institutional upper limit of Normal creatinine: within normal institutional limits 7. Patients must be HLA-A*2402 8. Patients must have recovered from all reversible treatment toxicity from prior chemotherapy, radiotherapy or surgery. 9. 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. 10. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patients receiving any other investigational agents. 2. History of significant gastrointestinal bleeding that required intervention within the prior 1 month is ineligible; inherited bleeding diathesis or coagulopathy. 3. Serious non healing wound and peptic ulcer disease 4. Previous history of intestinal perforation 5. 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 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. 8. Women who are breast-feeding or pregnant are excluded from this study. 9. Patients who are judged as ineligible to attend study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event and Adverse Drug Reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of induction of specific CTL response | — |
Countries
Japan, Singapore, South Korea
Contacts
Public ContactMasahiro Katsuda
Wakayama medical university
Outcome results
None listed