Clinical trial · Interventional
Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer
A Phase I/IIa Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer
NCT01227772CI-TRIAL-00022668unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Active vaccination with tumor specific antigens and VEGFR1 HLA-A24 epitopes can improve survival of patients with advanced Gastric Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OTSGC-A24 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Weekly Cohort
- description
- The gastric cancer vaccine (OTSGC-A24) will be administered at a dose of 1 mg once a week
- interventionNames
- Biological: OTSGC-A24
- type
- EXPERIMENTAL
- label
- 2-weekly cohort
- description
- The gastric cancer vaccine (OTSGC-A24) will be administered at the dose of 1 mg every 2 weeks.
- interventionNames
- Biological: OTSGC-A24
- type
- EXPERIMENTAL
- label
- 3-weekly cohort
- description
- The gastric cancer vaccine (OTSGC-A24)will be administered at 1 mg very 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDAjani JA. Evolving chemotherapy for advanced gastric cancer. Oncologist. 2005;10 Suppl 3:49-58. doi: 10.1634/theoncologist.10-90003-49. PMID 16368871
- BACKGROUNDWagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245. PMID 16782930
- DERIVEDSundar R, Rha SY, Yamaue H, Katsuda M, Kono K, Kim HS, Kim C, Mimura K, Kua LF, Yong WP. A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. BMC Cancer. 2018 Mar 27;18(1):332. doi: 10.1186/s12885-018-4234-8. PMID 29587677