UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical trial of personalized peptide vaccination for standard therapy failed liver cancer patients. (except HCV positive patients in stage IV)
Title of the study (Brief title)	Randomized Phase II study of peptide vaccination for liver cancer.
Region	Japan

Condition
Condition	liver cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to standard therapy failed liver cancer patients (except HCV positive patients in stage IV). The aim of the study is to investigate immunological responses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
Key secondary outcomes	1. Evaluation of long-term prognosis (progression free survival and total survival). 2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	(1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide). Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose. Day 45: Final evaluation. The 1st treatment (total 6 times, every weeks) is finished
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	The subjects must satisfy the following conditions. 1) Patients must be diagnosed as standard therapy failed liver cancer.except HCV positive patients in stage IV) 2) Patients must be at a score level 0~1 of performance status (PS) (ECOG). 3) Patients must have IgG reactive to at least two of candidate peptides. 4)Patients must be expected to survive more than 3 months. 6) Patients must satisfy the followings: WBC is more than 2,500/mm3 Lymphocyte is more than 1,000/mm3 Hb is more than 8.0g/dl Platelet is more than 50,000/mm3 Serum Creatinine is less than 2.0mg/dl Total Bilirubin is less than 2.5mg/dl 6) Patients must be more 20 year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.
Key exclusion criteria	The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size	100

Research contact person
Name of lead principal investigator	Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Address	Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL	0942-27-5210
Email	yutani@med.kurume-u.ac.jp

Public contact
Name of contact person	Akira Yamada
Organization	Kurume University
Division name	Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Address	Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7572
Homepage URL
Email	akiymd@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 07 Day
Anticipated trial start date	2010 Year 05 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 05 Month 10 Day
Last modified on	2017 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=R000004353