UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study with Tegafur/Uracil and Peg-Interferon after TACE for hepatocelluler carcinoma
Acronym	A phase II study with Tegafur/Uracil and Peg-Interferon after TACE for hepatocelluler carcinoma
Scientific Title	A phase II study with Tegafur/Uracil and Peg-Interferon after TACE for hepatocelluler carcinoma
Scientific Title:Acronym	A phase II study with Tegafur/Uracil and Peg-Interferon after TACE for hepatocelluler carcinoma
Region	Japan

Condition
Condition	Advanced hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical effectiveness and safety of Peg-Interferon and oral Tegafur/Uracil after TACE as adjuvant therapy for advanced hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Safety profile

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	Combination chemotherapy with Peg-Interferon and oral Tegafur/Uracil
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)Histologically or clinically confirmed hepatocellular carcinoma 2)Measurable and hypervascular hepatocellular carcinoma on contrast CT 3)No indication or resistance hepatic resection and percutaneous treatment 4)No tumor thrombus in main portal vein 5)Child-Pugh score of A or B 6)Adequate bone marrow function 7)Ages 20years and above,under 80 years 8)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 9)Written informed consent
Key exclusion criteria	1)Allergic reaction to IFN and/or UFT 2)Positive by prick test of IFN 3)Severe liver damage after TAE 4)Autoimmune disease 5)Depression or mental neuropathic illness 6)Uncontrolled heart or renal desease 7)Pregnant or nursing 8)Extensive leukopenia or extensive thrombocytopia 9)Use Sho-saiko-to 10)Other uncontrolled severe illness 11)Other inappropriate patient
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroki Ueda
Organization	Wakayama Medical University
Division name	The third department of Internal medicine
Zip code
Address	811-1 Kimiidera, Wakayama city,641-0012,Japan
TEL	073-441-0619
Email

Public contact
Name of contact person	1st name Middle name Last name Hiroki Ueda
Organization	Wakayama Medical University
Division name	The third department of Internal Medicine
Zip code
Address	811-1,Kimiidera,Wakayama city, 641-0012,Japan
TEL	073-441-0619
Homepage URL
Email	hu11@wakayama-med.ac.jp

Sponsor
Institute	The third department of Internal Medicine, Wakayama Medical University
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)

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	2005 Year 11 Month 02 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	Terminated
Date of protocol fixation	2005 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date	2005 Year 10 Month 01 Day
Last follow-up date	2008 Year 01 Month 01 Day
Date of closure to data entry	2008 Year 02 Month 01 Day
Date trial data considered complete	2008 Year 02 Month 01 Day
Date analysis concluded	2008 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 11 Month 02 Day
Last modified on	2008 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000348

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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