Patients after curative resection for esophageal cancer with NY-ESO-1 antigen expression
Conditions
Interventions
IMF-001-treated group: IMF-001 0.2mg will be administered 6 times every 2 weeks, and 9 times every 4 weeks.
IMF-001-untreated group: IMF-001 is not administered.
Sponsors
Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with esophageal squamous cell carcinoma, which is histologically or cytologically confirmed. 2) Tumor cells are judged expressing NY-ESO-1 antigen by immunohistochemistry. 3) Preoperative chemotherapy with regimen containing fluoropyrimidine and platinum. 4) Patients underwent esophagectomy with 2 or 3-field lymphadenectomy (R0-resection : UICC). 5) Clinical stage is either II or III or IV with supraclavicular lymph node metastasis (UICC Ver.7) . 6) Trial dosing is started within 12 weeks after resection. 7) Patients should be 20 years or older at enrollment. 8) No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; WBC count : >=2,000/mm3 Hemoglobin : >=8.0g/dL Platelet count : >=75,000/mm3 Serum total bilirubin : <=1.5 x ULN AST and ALT : <=2.5 x ULN Serum creatinine : <=2 x ULN 9) Agree to use birth control including condom etc. from the time of obtaining the first consent to 6 months after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization). 10) Given written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients undergoing treatment with radiotherapy for esophageal cancer. 2) Patients with double cancer. 3) Patients with autoimmune disease. 4) HIV antibody positive. 5) History of serious anaphylaxis. 6) Within 4 weeks after treatment with immune suppressant, immune enhancer or systemically administered adrenocorticosteroid. 7) Pregnant or breast-feeding females and females who have a possibility of pregnancy. 8) Patients who are administered the other investigational product within 12 weeks of the secondary entry. 9) Any other inadequacy for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Countries
Japan
Contacts
Public ContactHiroshi Miyamoto
Secretariat of clinical trial coordinating committee (none)
Outcome results
None listed