Unique ID issued by UMIN | UMIN000003772 |
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Receipt number | R000004570 |
Scientific Title | Continuous administration study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy. |
Date of disclosure of the study information | 2010/06/21 |
Last modified on | 2014/07/10 16:41:38 |
Continuous administration study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.
Continuous administration study of peptid vaccination to prevent recurrence of HCV-positive liver cancer.
Continuous administration study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.
Continuous administration study of peptid vaccination to prevent recurrence of HCV-positive liver cancer.
Japan |
liver cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The Object of the study is to investigate safety and immunological and clinical effects of peptide-cocktail vaccines consist of 10 cancer-derived peptides and 3 HCV-derived peptides emulsified with incomplete Freund's adjuvant.
Safety
Exploratory
Pragmatic
Phase I,II
Safety, to evaluate with CTCAE v4.0
Profiles of immunological responses.
Recurrence-free survival time
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Vaccine |
<1st Treatment : 6 times, every weeks>
Interview :Day1, 29, 57, 85, 113, 141
Treatment : Day1, 29, 57, 85, 113, 141
Watching adverse events : Day1, 29, 57, 85, 113, 141
Immune function test : Day141
Blood test : Day141
Abdominal Echo :Day1, 29, 57, 85, 113, 141
<1st Treatment : 6 times, every weeks>
Interview : Day197, 253, 309, 365, 421, 477
Treatment : Day197, 253, 309, 365, 421, 477
Watching adverse events : Day197, 253, 309, 365, 421, 477
Immune function test : Day141
Blood test : Day197, 253, 309, 365, 421, 477
Abdominal Echo : Day197, 253, 309, 365, 421, 477
<3rd Treatment~ :2nd treatment is repeated>
20 | years-old | <= |
81 | years-old | >= |
Male and Female
The subjects must satisfy the following conditions.
1)HCV-positive patients with liver cancer who have undergone radical therapy and no legion has been confirmed by ultrasonography and/or CT.
2)No lesion of liver cancer confirmed by ultrasonography and CT.
3) Patients must be at a score level
0~1 of performance status (PS) (ECOG).
4) Patients must satisfy the followings:
WBC is more than 2,200/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
5) Patients must be at a total score level 7 or less of Child-Pugh
6) Patients must be more 20 year-old or more to 80 years old or less.
7)Patients must be expected to survive more than 3 months.
8) Written informed consent must be obtained from patients.
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 multiple active cancers
3)Patients suspected with immunodeficiency and opportunistic infection.
4) Patients with the past history of severe allergic reactions.
5)Patients who are during pregnancy, lactation expectant, and desiring future fertility.
6)Patients with a score II or more of hepatic encephalopathy.
7) Patients who are judged inappropriate for the clinical trial by doctors.
3
1st name | |
Middle name | |
Last name | Shigeru Yutani |
Kurume University
Cancer Vaccine Center
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
0942-27-5210
yutani@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
0942-31-7572
akiymd@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
None
Other
NO
2010 | Year | 06 | Month | 21 | Day |
Unpublished
Completed
2010 | Year | 05 | Month | 20 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 06 | Month | 17 | Day |
2014 | Year | 07 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004570
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