UMIN-CTR Clinical Trial

Basic information
Public title	Combination therapy of 5-Fluorouracil/gemcitabine/cisplatin for advanced hepatocellular carcinoma with extrahepatic metastases -A pilot study-
Acronym	Combination therapy of 5FU/gemcitabine/CDDP for advanced HCC with extrahepatic metastases -A pilot study-
Scientific Title	Combination therapy of 5-Fluorouracil/gemcitabine/cisplatin for advanced hepatocellular carcinoma with extrahepatic metastases -A pilot study-
Scientific Title:Acronym	Combination therapy of 5FU/gemcitabine/CDDP for advanced HCC with extrahepatic metastases -A pilot study-
Region	Japan

Condition
Condition	Hepatocellular carcinoma with extrahepatic metastases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy and safety of the combination therapy of 5FU/gemcitabine/CDDP for advanced hepatocellular carcinoma with extrahepatic metastases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response for extrahepatic metastases
Key secondary outcomes	Overall survival Safety

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	The combination therapy of 5FU/gemcitabine/CDDP. Contunue the protocol as long as progression disease is observed.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Unresectable hepatocellular carcinoma with extrahepatic metastases. Child Pugh A. Not suitable candidate for S-1 and IFN therapy. Without ascites. Without hepatic coma. Eastern cooperative Oncology Group 0, or 1. WBC > 2000/mm3 Plt > 100000/mm3 Hb > 10.0g/dl Total Bilirubin < 2.0mg/dl Albumin > 2.8g/dl Creatine < 1.2mg/dl Prothromin time > 40 percentage
Key exclusion criteria	With other malignant disease. A pregnant woman, or a woman suspected of pregnancy. With severe infectious disease. With history of severe allergy. With severe renal function disease. With S-1. With severe allergy for 5FU, gemcitabine, or CDDP. With severe bone marrow supression. With pulmonary fibrosis. With the history of radiotharpy for lung.
Target sample size	5

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazuaki Chayama
Organization	Hiroshima University
Division name	Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical Sciences
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name Kiminori Uka
Organization	Hiroshima University
Division name	Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Bio
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Homepage URL
Email

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 05 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 17 Day
Date of IRB	2007 Year 05 Month 07 Day
Anticipated trial start date	2007 Year 05 Month 07 Day
Last follow-up date	2009 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2007 Year 05 Month 22 Day
Last modified on	2019 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000863