Unique ID issued by UMIN | UMIN000004540 |
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Receipt number | R000005426 |
Scientific Title | Clinical trial of chondroitin-glucuronate C5-epimerase-derived peptide vaccine for hepatocellular carcinoma |
Date of disclosure of the study information | 2010/11/15 |
Last modified on | 2012/10/31 13:24:22 |
Clinical trial of chondroitin-glucuronate C5-epimerase-derived peptide vaccine for hepatocellular carcinoma
A SART2 peptide vaccine for hepatocellular carcinoma
Clinical trial of chondroitin-glucuronate C5-epimerase-derived peptide vaccine for hepatocellular carcinoma
A SART2 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 chondroitin-glucuronate C5-epimerase-derived peptide vaccine in HCC patients
Safety,Efficacy
Exploratory
Phase I
Evaluation of adverse events and immune responses
Evaluation of recurrence rate and tumor marker after HCC treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine |
Three times injection of chondroitin-glucuronate C5-epimerase-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
Takara-machi 13-1, Kanazawa city, Ishikawa
076-265-2235
1st name | |
Middle name | |
Last name | Eishiro Mizukoshi |
Kanazawa University Hospital
Department of Gastroenterology
076-265-2235
Department of Gastroenterology, Kanazawa University Hospital
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
NO
2010 | Year | 11 | Month | 15 | Day |
Published
Completed
2010 | Year | 10 | Month | 20 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 11 | Day |
2012 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005426
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