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Postoperative adjuvant immunochemotherapy of tumor specific peptide vaccine plus CDDP+5FU chemotherapy for esophageal cancer patients with pathological lymph node metastasis who underwent no preoperative treatment- Multicenter Phase II trial

Postoperative adjuvant immunochemotherapy of tumor specific peptide vaccine plus CDDP+5FU chemotherapy for esophageal cancer patients with pathological lymph node metastasis who underwent no preoperative treatment- Multicenter Phase II trial - Postoperative adjuvant tumor specific peptide vaccine plus FP chemotherapy for pN(+) esophageal cancer patients without preoperative therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003556
Enrollment
60
Registered
2010-05-03
Start date
2010-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Patients with HLA-A*2402 will undergo 2 set of weekly vaccination for 5 weeks followed by byweekly vaccinotion for 10 weeks in addition to standard therapy of 2 set of CDDP plus 5FU adjuvant chemother

Sponsors

Kinki University Faculty of Medicine
Lead Sponsor
Human Genome Center, Institute of Medical Science, The University of Tokyo
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with esophageal SCC who underwent currative (R0) resection without preoperative treatment and had pathological LN metastases 2)Laboratory values as follows Hemoglobin > 8.0g/dL 2000/mm3 < WBC < 15000mm3 Platelet count > 70000/mm3 Total bilirubin < 1.5mg/dL Asparate transaminase < 150U/L Alanine transaminase < 150U/L Serum creatinine < 3.0mg/dL PaO2 > 70mmHg 3)ECOG performance status 0-1 4)Age between 20 to 84 5)Male and female 6)Able and willing to give valid written informed consent

Exclusion criteria

Exclusion criteria: 1)Infectious disease (ex. patients with high fever of 38.5 degrees C or more, et cetra) 2)Severe heart disease or past history of the disease 3)Severe postoperative complications (ileus, interstitial pneumonia, uncontrolled DM, renal failure, cirrhosis, et cetra) 4)Severe mental disorder 5)Another active malignant disease 6)Brestfeeding and pregnancy (woman of child bearing potential) 7)Man with an intention to get with child 8)Autoimmune disease 9)Retention of pericardial fluid to cause heart failure or pericarditis 10)Decision of unsuitableness by principal investigator or physician-in-charge

Design outcomes

Primary

MeasureTime frame
Relapse free Survival

Secondary

MeasureTime frame
Disease free survival Overall survival Adverse event Feasibility immunoresponse

Countries

Japan

Contacts

Public ContactTakushi Yasuda

Kinki University Faculty of Medicine Department of Surgey

tyasuda@surg.med.kindai.ac.jp072-366-0221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026