Clinical trial · Interventional
Peptide Vaccination in Treating Patients With Esophageal Cancer
Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
NCT00682227CI-TRIAL-00001484unknownPhase 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 is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
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 |
|---|---|---|---|
| TTK, LY6K, and IMP-3 peptides | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: TTK, LY6K, and IMP-3 peptides
Primary outcomes (1)
- measure
- Safety (toxicities as assessed by NCI CTCAE version 3)
- timeFrame
- 3 months
Secondary outcomes (1)
- measure
- Immunological and clinical response
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * DISEASE CHARACTERISTICS 1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy PATIENTS CHARACTERISTICS 1. ECOG performance status 0-2 2. Age≧20 years, 80≦years 3. WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits 4. Patients must be HLA-A2402 5. Able and willing to give valid written informed consent Exclusion Criteria: 1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breastfeeding 3. Serious bleeding disorder 4. Serious infections requiring antibiotics 5. Concomitant treatment with steroids or immunosuppressing agent 6. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (5)
- BACKGROUNDLin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene. 2002 Jun 13;21(26):4120-8. doi: 10.1038/sj.onc.1205518. PMID 12037668
- BACKGROUNDHasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7. PMID 12460921
- BACKGROUNDSuda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x. PMID 17784873
- BACKGROUNDIshikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243. PMID 18089789
- DERIVEDKono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14. PMID 19459850