UMIN-CTR Clinical Trial

Basic information
Public title	Treatment with cancer peptide vaccine cocktail derived from URLC10, KIF20A, VEGFR-1 and VEGFR-2 for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Acronym	Treatment with cancer peptide vaccine cocktail for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Scientific Title	Treatment with cancer peptide vaccine cocktail derived from URLC10, KIF20A, VEGFR-1 and VEGFR-2 for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Scientific Title:Acronym	Treatment with cancer peptide vaccine cocktail for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Region	Japan

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

Objectives
Narrative objectives1	Tp evaluate the safety and efficacy of peptide vaccine cocktail therapy in esophageal cancer refractory or intolerable to standard therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety: Adverse event Efficacy: Overall survival
Key secondary outcomes	immunological evaluation Progression free survival Response rate (RECISTv1.1, irRC) QOL

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	peptides derived from URLC10, KIF20A, VEGFR-1 and VEGFR-2
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients must have histologically or cytologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous carcinoma of the esophagus. Patients must be diagnosed to be refractory or intolerable to standerd anti-cancer drugs such as fluoropyrimidine, platinum and Taxane. KPS of 80 to 100. Patients must be HLA-A02 or HLA-A24. Life expectancy at least 3 months. Age >= 20 years. Patients must have normal organ and marrow function as defined below: white blood cells; >=2000,<=15000 platelets; >= 50000 total bilirubin; <=3.0mg/dL AST; <=150IU/L ALT; <=150IU/L Creatinine; <=2.0mg/dL The willingness to sign a written informed consent document.
Key exclusion criteria	Patients who received all peptides derived from VEGFR-1, VEGFR-2, URLC10 and KIF20A. Patients with other malignant tumor except for mucosal lesion. Primary tumor is widely invaded to other organs and is strongly concerned to bleed. History or intercurrent illness of intestinal pneumonia or pulmonary fibrosis. Symptomatic CNS metastasis. Patients with pleural effusion, abdominal effusion or pericardial effusion requiring a puncture or drainage. Severe infection or suspicious of severe infection. Severe mental disorder or severe neurological disorder. Uncontrolled heart, lung, kidney, or liver disease. Other uncontrolled intercurrent illness. Previous history of myocardial infarction, severe unstable angina, CABG surgery, congestive heart failure, cerebrovascular disease, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism within 12 months prior to drug administration. Uncured traumatic injury (including traumatic bone fracture). Bleeding diathesis (including the fatal aneurysm) or coagulopathy. Continuous administration of antithrombotic drugs except for aspirin. Treatment-resistant hypertension. Heart failure under treatment. Patients receiving other investigational agents. Women who are breast-feeding or pregnant. Patients without intention to contraception. Patients who are judged as ineligible to attend study by investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Yamaue
Organization	Wakayama medical university
Division name	2nd. department of Surgery
Zip code	6418510
Address	811-1 Kimiidera Wakayama-city, Wakayama
TEL	073-441-0613
Email	yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Katsuda
Organization	Wakayama medical university
Division name	2nd. department of Surgery
Zip code	6418510
Address	811-1 Kimiidera Wakayama-city, Wakayama
TEL	073-441-0613
Homepage URL
Email	katsuda@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	2nd dept of Surg, Wakayama medical Univ.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Wakayama Medical University Ethics Review Committee
Address	811-1 Kimiidera Wakayama-city, Wakayama
Tel	074-447-2300
Email	wa-rinri@wakayama-med.ac.jp

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	和歌山県立医科大学（和歌山県）、北海道がんセンター（北海道）、東北大学（宮城県）、千葉大学（千葉県）、東海大学（静岡県）、岐阜大学（岐阜県）、川崎医科大学（岡山県）、鹿児島大学（鹿児島県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 20 Day
Date of IRB	2013 Year 08 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2017 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 14 Day
Last modified on	2020 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016004