UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of transarterial chemoembolization using Cisplatin powder and miriplatin in patients with hepatocellular carcinoma
Title of the study (Brief title)	Phase I study of doubleplatinum TACE for HCC
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of transarterial chemoembolization using Cisplatin powder and miriplatin in patients with hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	anti-tumor effect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	miriplatin 60mg cisplatin 50mg ethyl ester of iodinated poppy-seed oil fatty acid 6ml
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Substantial enhancement during arterial phase followed by a washout with corona-like peripheral enhancement in equilibrium phase by dynamic CT 2)4 weeks from the prior therapy 3)Anticipated survival is less than 3 months 4)Child A or B 5)Adequate baseline organ and marrow function as defined below: hemoglobin: >=9.5 g/dL WBC count: >=3,000/mm3 platelet count: >=50,000 mm3 total bilirubin: =<3.0 mg/dL AST(GOT): =<ULN x 5 ALT(GPT): =<ULN x 5 albumin >=2.5g/dl serum creatinine: =<1.5 mg/dL 6)ECOG performance status (PS) 0-1 7)Written informed consent
Key exclusion criteria	1)History of hypersensitivity reaction 2)Other severe complications, such as uncontrollable diabetes or heart failure, renal insufficiency, liver failure 3)Active another cancer 4)Pregnant or possibility pregnancy or nursing woman 5) Physician judged improper to entry this trial
Target sample size	10

Research contact person
Name of lead principal investigator	Noriyuki Nishino
Organization	Southern TOHOKU General Hospital
Division name	Department of Gastroenterology
Address	7-115, Yatsuyamada, Koriyama-shi, 963-8563Fukushima
TEL	024-934-5322
Email	n.nishino1@mt.strins.or.jp

Public contact
Name of contact person	Koichi Hamada
Organization	Southern TOHOKU General Hospital
Division name	Department of Gastroenterology
Address	7-115, Yatsuyamada, Koriyama-shi, 963-8563Fukushima
TEL	024-934-5322
Homepage URL
Email	koichi.hamada@mt.strins.or.jp

Sponsor
Institute	Southern TOHOKU General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 10 Day
Anticipated trial start date	2013 Year 04 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 05 Day
Last modified on	2019 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012198