UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Postoperative adjuvant tumor specific peptide vaccine for pN(+) esophageal cancer patients with preoperative therapy
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Relapse free Survival
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	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.
Interventions/Control_2	Patients without HLA-A*2402 will be followed up with no therapy in principle.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	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
Key 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
Target sample size	60

Research contact person
Name of lead principal investigator	Takushi Yasuda
Organization	Kindai University Faculty of Medicine
Division name	Department of Surgery
Address	377-2, Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL	072-366-0221
Email	takushi-yasuda6008@med.kindai.ac.jp

Public contact
Name of contact person	Takushi Yasuda
Organization	Kindai University Faculty of Medicine
Division name	Department of Surgery
Address	377-2, Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL	072-366-0221
Homepage URL
Email	takushi-yasuda6008@med.kindai.ac.jp

Sponsor
Institute	Kindai University Faculty of Medicine, Department of Surgery
Institute
Department

Funding Source
Organization	Captivation Network (the patients' group), Kindai University Faculty of Medicine and Oncotherapy Science Co., Ltd
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Human Genome Center, Institute of Medical Science, The University of Tokyo The University of Chicago, Faculty of Medicine
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	近畿大学医学部附属病院 (Kindai University Faculty of Medicine)

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 09 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2018 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 05 Month 01 Day
Last modified on	2018 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004284