UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000005634|
|Scientific Title||Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.|
|Date of disclosure of the study information||2011/05/24|
|Last modified on||2014/06/24|
|Public title||Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
|Acronym||Phase II study of peptide vaccination in HCV positive patients with advanced liver cancer.|
|Scientific Title||Phase II clinical trial of personalized peptide vaccination for HCV positive patients with advanced liver cancer.
|Scientific Title:Acronym||Phase II study of peptide vaccination in HCV positive patients with advanced liver cancer.|
|Classification by specialty||
|Classification by malignancy||Malignancy|
|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 the safety, immunological responses and antitumor activity.|
|Basic objectives -Others|
|Developmental phase||Phase II|
|Primary outcomes||Evaluation of antitumor activity (overall survival) of peptide vaccination.|
|Key secondary outcomes||1.Evaluation of response rate and long-term prognosis (overall survival).
2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0).
3.Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
|In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.|
|Basic design||Single arm|
|Blinding||Open -no one is blinded|
|No. of arms||1|
|Purpose of intervention||Treatment|
|Type of intervention||
|Interventions/Control_1||personalized peptide vaccine plus best supportive care (BSC)
( total 8 times, every 1 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, 43, 50: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 50: Final evaluation.
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, corticosteroids, and transfusion) during the vaccination.
|In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.|
|Gender||Male and Female|
|Key inclusion criteria||The subjects must satisfy the following conditions.
1) HCV positive patients with standard therapy failed stage VI liver cancer.
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 in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
6) Patients must satisfy the followings:
WBC is more than 2,000/mm3
Lymphocyte is more than 900/mm3
Hb is more than 8.0g/dl
Platelet is more than 40,000/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) Patients must be expected to survive more than 3 months.
8) Written informed consent must be obtained from patients.
9) Prior treatment are allowed and must complete before random assignment with full recovery of related toxicity.
|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)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3) Patient who has doubt of immune deficiency disease or opportunistic infection.
4) Patients with the past history of severe allergic reactions.
2) Women during pregnancy or breast-feeding.
6) Patient of hepatic encephalopathy two degrees or more
7) Patients with brain metastasis.
8) Patients who are judged inappropriate for the clinical trial by doctors.
|Target sample size||41|
|Research contact person|
|Name of lead principal investigator||
|Division name||Department of Immunology and Immunotherapy|
|Address||Asahi-machi 67, Kurume, Fukuoka 830-0011|
|Name of contact person||
|Division name||Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division|
|Address||Asahi-machi 67, Kurume, Fukuoka 830-0011|
|Institute||Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
|Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.
|Organization||The Ministry of Education, Culture, Sports, Science, and Technology, Japan
|Category of Funding Organization|
|Nationality of Funding Organization||Japan|
|Other related organizations|
|Co-sponsor||Hirosaki University , Fukusima prefectural medical University, Showa University, Kinki University
|Name of secondary funder(s)||Kurume University
|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Institutions||久留米大学病院(福岡県)、弘前大学病院(青森県)、福島県立医科大学病院(福島県)、昭和大学病院(東京都)、近畿大学病院(大阪府)Kurume University Hosipital, Hirosaki University Hospital, Fukusima prefectural medical University Hospital, Showa University Hospital, Kinki University Hosipital
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date|
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
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