Clinical trial · Interventional
Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer
Tumor Vaccine Therapy Against Advanced Esophageal Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
NCT00753844CI-TRIAL-00006681completedPhase 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 esophageal 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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| URLC10 | 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 esophageal 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. Passing from radiation therapy more than four 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. Disease to the central nervous system 5. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (0)
Data not yet available
No reference posted for this study.