Clinical trial · Interventional
Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Gastric Cancer
Tumor Vaccine Therapy Against Advanced Gastric Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
NCT00845611CI-TRIAL-00006673completedPhase 1ClinicalTrials.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)
The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent 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 |
|---|---|---|---|
| peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety(Phase I:toxicities as assessed by NCI CTCAE version3)
- timeFrame
- 28 days after beginning protocol
Secondary outcomes (2)
- measure
- efficacy(Feasibility as evaluated by RECIST)
- timeFrame
- 28 days after beginning protocol
- measure
- evaluate immunological responses
- timeFrame
- 28 days after beginning protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have Advanced or recurrent gastric cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy 2. WHO performance status of 0 to 2 3. Age ≥ 20 years, ≤80 years 4. The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible 5. Passing from previous treatment more than two weeks. 6. Expected survival of at least 3 months 7. WBC≥ 1,500/mm³ WBC≤ 15,000/mm³ Platelet count ≥ 50,000/mm³ Total bilirubin≤ 3 x the institutional normal upper limits AST, ALT ≤ 3 x the institutional normal upper limits Creatinine ≤ 3 x the institutional normal upper limits 8. Patients must be HLA-A2402 9. Able and willing to give valid written informed consent Exclusion Criteria: 1. Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding 2. Serious infections requiring antibiotics 3. Concurrent treatment with steroids or immunosuppressing agent 4. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (1)
- DERIVEDIshikawa H, Imano M, Shiraishi O, Yasuda A, Peng YF, Shinkai M, Yasuda T, Imamoto H, Shiozaki H. Phase I clinical trial of vaccination with LY6K-derived peptide in patients with advanced gastric cancer. Gastric Cancer. 2014 Jan;17(1):173-80. doi: 10.1007/s10120-013-0258-6. Epub 2013 Apr 24. PMID 23613128