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A clinical study on the safety of therapy against hepatocarcinoma: combination of dendric cell and TAE followed by RFA.

Safety of combined therapy against HCC with TAE, dendric cell and RFA.

Shigeharu Fujieda

Nakamoto Yasunari

Faculty of Medical Sciences, University of Fukui

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

ynakamot@u-fukui.ac.jp

Akazawa Yu

Faculty of Medical Sciences, University of Fukui

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

+81-776-61-3111

aka0124@u-fukui.ac.jp

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

(1)Patients must be diagnosed as primary hepatocellular carcinoma pathologically or from images.
(2)Patients must be inoperable.
(3)Patients must have Karnofsky Performance Status above 70.
(4)Patients must have one or more tumor of maximum diameter larger than 2.5 cm. The number of tumor must not exceed 5.
(5)Patients who can be cured with TAE and radiofrequency ablation.
(6)Patient must be over 20 years old at registration.
(7)Liver damage or Child-pugh classificaion must be A or B according to latest clinical guideline for primary hepatocellular carcinoma.
(8)Bone marrow and kidney function should be adequate at qualification confirmation.
(9)Written consent should be obtained for participation to this study.
(10)Patient must be capable of outpatient visits.

(1)Patients must not have heart disorder, kidney disorder, respiratory disorder, hematopathy, clotting disorder, or other serious complication.
(2)Patients must not be HIV positive.
(3)Patients must not have carcinoma nor immunodeficiency in past history.
(4)Patients must not have splenectomy nor splen radiation in past history.
(5)Patients must not have allo organ transplantation in past history.
(6)Patients must not subjected to continuous whole body administration of adrenal cortical steroid or antihistaminic.
(7)Patients must have no surgery, chemotherapy nor radiation within 4 weeks before blood collection for treatment in this study. In addition, patients are also excluded if they have not recovered enough from those therapies above.
(8)Female patients are excluded from the study when they are pregnant, possibly pregnant, or when they want to be pregnant or they are feeding.
(9)Patients must be excluded when expected to be difficult to follow-up.
(10)Patients must be excluded when principal investigator judge as inadequate.

Both

Hepatocellular carcinoma

Trans-arterial embolization (TAE) with more than 5.0 x 10^6 dendritic cells is performed.
Radiofrequency ablation is performed from 3-6 weeks after TAE and DCs.

Efficacy

Safety

Pending

+81-3-5244-5751

Feb. 18, 2019