Unique ID issued by UMIN | UMIN000003557 |
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Receipt number | R000004284 |
Scientific Title | Postoperative adjuvant immunotherapy of tumor specific peptide vaccine for esophageal cancer patients with pathological lymph node metastasis who underwent preoperative therapy followed by surgery- single institute exploratory Phase II trial |
Date of disclosure of the study information | 2010/05/03 |
Last modified on | 2018/11/13 09:30:37 |
Postoperative adjuvant immunotherapy of tumor specific peptide vaccine for esophageal cancer patients with pathological lymph node metastasis who underwent preoperative therapy followed by surgery- single institute exploratory Phase II trial
Postoperative adjuvant tumor specific peptide vaccine for pN(+) esophageal cancer patients with preoperative therapy
Postoperative adjuvant immunotherapy of tumor specific peptide vaccine for esophageal cancer patients with pathological lymph node metastasis who underwent preoperative therapy followed by surgery- single institute exploratory Phase II trial
Postoperative adjuvant tumor specific peptide vaccine for pN(+) esophageal cancer patients with preoperative therapy
Japan |
esophageal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
This clinical trial is the single institute exploratory phase II trial to evaluate the effect of HLA A2402-restricted epitope peptide derived from new tumor specific antigens of URLC10, CDCA1 and KOC1 about suppression of postoperative recuurrence for esophageal cancer patients with pathological lymph node metastasis regardless of preoperative therapy
Efficacy
Exploratory
Pragmatic
Phase II
Relapse free Survival
Esophageal cancer specific survival
Overall survival
Adverse event
Feasibility
immunological response
Expression of tumor specific antigen
Expression of HLA calss I
Expression of CD(+ T cell and PDL1
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Vaccine |
Patients with HLA-A*2402 will undergo 2 set of weekly vaccination for 5 weeks followed by byweekly vaccinotion for 10 weeks. On each vaccination day, 1mg of the HLA-A*2402-restricted URLC10, CDCA1 and KOC1 peptide mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Patients without HLA-A*2402 will be followed up with no therapy in principle.
20 | years-old | <= |
85 | years-old | > |
Male and Female
1)Patients with esophageal SCC who underwent currative (R0) resection after 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
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
60
1st name | |
Middle name | |
Last name | Takushi Yasuda |
Kindai University Faculty of Medicine
Department of Surgery
377-2, Ohno-Higashi, Osaka-sayama, Osaka, Japan
072-366-0221
takushi-yasuda6008@med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Takushi Yasuda |
Kindai University Faculty of Medicine
Department of Surgery
377-2, Ohno-Higashi, Osaka-sayama, Osaka, Japan
072-366-0221
takushi-yasuda6008@med.kindai.ac.jp
Kindai University Faculty of Medicine, Department of Surgery
Captivation Network (the patients' group), Kindai University Faculty of Medicine and Oncotherapy Science Co., Ltd
Other
Human Genome Center, Institute of Medical Science, The University of Tokyo
The University of Chicago, Faculty of Medicine
NO
近畿大学医学部附属病院 (Kindai University Faculty of Medicine)
2010 | Year | 05 | Month | 03 | Day |
Partially published
Completed
2009 | Year | 11 | Month | 09 | Day |
2010 | Year | 01 | Month | 01 | Day |
2018 | Year | 04 | Month | 02 | Day |
2010 | Year | 05 | Month | 01 | Day |
2018 | Year | 11 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004284
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