Unique ID issued by UMIN | UMIN000005677 |
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Receipt number | R000006715 |
Scientific Title | Clinical trial of human homologue of Prp24p-derived peptide vaccine for hepatocellular carcinoma |
Date of disclosure of the study information | 2011/06/01 |
Last modified on | 2014/11/30 09:13:07 |
Clinical trial of human homologue of Prp24p-derived peptide vaccine for hepatocellular carcinoma
A SART3 peptide vaccine for hepatocellular carcinoma
Clinical trial of human homologue of Prp24p-derived peptide vaccine for hepatocellular carcinoma
A SART3 peptide vaccine for hepatocellular carcinoma
Japan |
Hepatocellular carcinoma (HCC)
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate safety and efficacy of human homologue of Prp24p-derived peptide vaccine in HCC patients
Safety,Efficacy
Evaluation of adverse events and immune responses
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine |
Three times injection of human homologue of Prp24p-derived peptide after HCC local treatments every 2 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1)HCC must be diagnosed
2)Karnofsky Performance Status is equal to or more than 70%
3)Patients must be equal to or more than 20 years old and written informed consent must be obtained
4)WBC is equal to or more than 2,000/mm3
5)Platelet is equal to or more than 50,000/mm3
6)Hb is equal to or more than 8.5 g/dl
7)Level of liver damage must be A or B
8)Serum Cr is equal to or less than 1.5 mg/dl
1)Severe complications associated with heart, kidney, lung, blood and coagulability
2)Infection of HIV
3)Past medical history of malignancy
4)Surgical treatment, chemotherapy and radiation therrapy within 4 weeks
5)Past medical history of Immunodeficiency, splenectomy and radiation of spleen
6)medical treatments with steroid
7)Patients who are during lactation
8)Patients who are during pregnancy and expected pregnancy
9)Past history of organ transplantation
10)Patients who are predicted a difficulty of following clinical course
11)Patients who are judged inappropriate for clinical trial
12
1st name | |
Middle name | |
Last name | Shuichi Kaneko |
Kanazawa University Hospital
Department of Gastroenterology
13-1 Takara-machi, Kanazawa, Ishikawa
076-265-2235
eishirom@m-kanazawa.jp
1st name | |
Middle name | |
Last name | Eishiro Mizukoshi |
Kanazawa University Hospital
Department of Gastroenterology
Kanazawa, Ishikawa
076-265-2235
eishirom@m-kanazawa.jp
Department of Gastroenterology, Kanazawa University Hospital
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Japan
NO
金沢大学附属病院(石川県)
2011 | Year | 06 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 02 | Month | 02 | Day |
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 05 | Month | 31 | Day |
2014 | Year | 11 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006715
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