Unique ID issued by UMIN | UMIN000011854 |
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Receipt number | R000013855 |
Scientific Title | Phase I study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2016/09/26 09:03:52 |
Phase I study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma
Phase I study of DC immunotherapy for HCC patients
Phase I study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma
Phase I study of DC immunotherapy for HCC patients
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To assess the safety of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for advanced HCC patients refractory to standard therapy
Safety
Phase I
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Vaccine |
Administration of DC vaccine 7 times, every two weeks, which quality was well controlled for three weeks culture and maturation of DCs after apheresis.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Diagnostic imaging of HCC that can be evaluated by RECIST
2) Refractory HCC for standard therapies or recurrence HCC after hepatectomy with chemotherapy and/or radiation therapy resistance
3) Performance status (ECOG) 0, 1, 2
4) Patients expected for completion of 7 times administration of DC vaccination
5) Adequate hematologic, hepatic, renal, and cardiac function
WBC >= 1,500/mm3
Absolute lymphocyte count >= 500/mm3
Hemoglobin >= 8.0g/dL
Total bilirubin <= 2.0mg/dL
Creatinine <= 2.0 mg/dL
Platelet >= 50,000/mm3
AST and ALT within 5 times of reference value
6) Written informed consent
1) Sever hemorrhagic diathesis
PT <50%
APTT >60%
Doctors judgment of severe bleeding tendency
2) Carrier of HBV, HTLV-1, HIV and so on
3) Severe comorbidity of heart disease (NYHA classIII, IV)
4) Intolerable cardiovascular disease for the apheresis
5) Past history of autoimmune disease (PSS, Sjogren syndrome, ITP, MS, RA etc.)
6) During treatment with immunosuppressive agents
7) Severe allergy with penicillin or picibanil
8) Pantients with adverse events of CTCAE v4.0 >= grade 3 of nonhematological toxicity, or >= grade 4 of hematological toxicity
9) Pregnancy, nursing women
10) Male hope to impregnate
11) Patients whom doctors judged inadequate to the enrollment of this study by other reasons
5
1st name | |
Middle name | |
Last name | Keiichi Suzuki |
Kitasato Institute Hospital
Surgery
5-9-1, Shirogane, Minato-ku, Tokyo, Japan
+81-3-3444-6161
k1suzuki@me.com
1st name | |
Middle name | |
Last name | Osamu Takeuchi |
Kitasato Institute Hospital
Biomedical laboratory
5-9-1, Shirogane, Minato-ku, Tokyo, Japan
+81-3-3444-6161
take-osa@insti.kitasato-u.ac.jp
Kitasato Institute Hospital
none
Self funding
None
Tella, Inc
NO
北里研究所病院
2013 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 28 | Day |
2013 | Year | 10 | Month | 05 | Day |
2014 | Year | 06 | Month | 01 | Day |
2014 | Year | 07 | Month | 30 | Day |
2013 | Year | 09 | Month | 24 | Day |
2016 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013855
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