UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of hepatic arterial infusion of cisplatin for unresectable intrahepatic cholangiocarcinoma
Title of the study (Brief title)	ICC-CDDP
Region	Japan

Condition
Condition	intrahepatic cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of hepatic arterial infusion of CDDP for intrahepatic cholangiocarcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	adverse events, overall survival, progression free survival

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	CDDP is administered at a dose of 65 mg/m2 into the hepatic artery. The treatment is repeated every 4 to 6 weeks until a maximum of 6 courses, the appearance of unacceptable toxicity, or disease progression.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) histologically confirmed ICC 2) unresectable or recurrent disease 3) ECOG Performance Status 0-1 4) having measurable lesion 5) adequate organ function 6) no prior chemotherapy using platinum compound 7) no prior radiotherapy 8) written informed consent
Key exclusion criteria	1) presence of uncontrollable ascites or pleural effusion 2) cerebral or bone metastasis 3) uncontrollable cardiovascular disease or prior myocardial infarction 4) active infection other than HBV or HCV 5) other malignancy 6) severe psychiatric disorder 7) severe drug allergy 8) pregnant or nursing
Target sample size	35

Research contact person
Name of lead principal investigator	Junji Furuse
Organization	Kyorin University
Division name	medical oncology
Address	6-5-1, Kashiwanoha, Kashiwa
TEL	03-3412-1111
Email	jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Kohei Nakachi
Organization	Sapporo Medical University
Division name	Gastroenterology
Address	Sapporo
TEL	0155-22-6600
Homepage URL
Email	knakachi-gi@umin.org

Sponsor
Institute	Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2007 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 03 Month 01 Day
Anticipated trial start date	2007 Year 08 Month 01 Day
Last follow-up date	2011 Year 07 Month 01 Day
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	2007 Year 08 Month 26 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000948