Unique ID issued by UMIN | UMIN000017688 |
---|---|
Receipt number | R000020502 |
Scientific Title | Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients. |
Date of disclosure of the study information | 2015/05/27 |
Last modified on | 2017/11/26 09:43:10 |
Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients.
CDDP-Microsphea TACE to epirbicin or miriplatin TACE refractory HCC
Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients.
CDDP-Microsphea TACE to epirbicin or miriplatin TACE refractory HCC
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
Feasibility and safty of CDDP-Microsphea TACE in epirbicin or miriplatin TACE refractory HCC with Child-Pugh score<8 patients.
Safety,Efficacy
Phase I,II
Dose Limiting Toxicity and Recommended
Dose
Objective response rate and disease control rate, frequency and severity of adverse event at recommended dose.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment |
cisplatin,microsphea
20 | years-old | <= |
Not applicable |
Male and Female
(1)Histologicaly or clinicaly confirmed HCC.
(2)No indication of liver resection or RFA, PEI.
(3)Epirbicin-TACE or Miripratin-TACE refractory HCC.
(4)HCC without Vp3, Vp4, Vv2, Vv3,B3, B4.
(5)HCC without extrahepatic lesion.
(6)ECOG Performance Status 0-2
(7)Without dysfunction of liver, renal, coagulopathy.
(8)Child-Pugh score<8
(9)Without administration of CDDP and Microsphea.
(10)Written informed consent.
(1)Massive type or infiltrative type of HCC.
(2)HCC supplied by extrahepatic artery.
(3)No hypersensitivity to contrast medium.
(4)Synchronous or metachronous malignancies within five years.
(5)Pregnant, lacting women or women with suspected pregnancy.
(6)Patients judged inappropriate for this study by physicians
50
1st name | |
Middle name | |
Last name | Michihisa Moriguchi |
Kyoto Prefectural University of Medicine
Gastroenterology and Hepatology
Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
075-251-5111
mmori@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Yuya Seko |
Kyoto Prefectural University of Medicine
Gastroenterology and Hepatology
Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
075-251-5111
yuyaseko@koto.kpu-m.ac.jp
Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
None
Self funding
NO
2015 | Year | 05 | Month | 27 | Day |
Unpublished
Terminated
2015 | Year | 05 | Month | 26 | Day |
2015 | Year | 07 | Month | 01 | Day |
2015 | Year | 05 | Month | 26 | Day |
2017 | Year | 11 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020502
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |