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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009921
Receipt No. R000011627
Scientific Title Transcatheter Arterial Chemo-Embolization (TACE) vs. Sorafenib in Patients with Hepatocellular Carcinoma Refractory to TACE: A Randomized Phase II Trial
Date of disclosure of the study information 2013/01/31
Last modified on 2017/08/07

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Basic information
Public title Transcatheter Arterial Chemo-Embolization (TACE) vs. Sorafenib in Patients with Hepatocellular Carcinoma Refractory to TACE: A Randomized Phase II Trial
Acronym Transcatheter Arterial Chemo-Embolization (TACE) vs. Sorafenib in Patients with Hepatocellular Carcinoma Refractory to TACE: A Randomized Phase II Trial
Scientific Title Transcatheter Arterial Chemo-Embolization (TACE) vs. Sorafenib in Patients with Hepatocellular Carcinoma Refractory to TACE: A Randomized Phase II Trial
Scientific Title:Acronym Transcatheter Arterial Chemo-Embolization (TACE) vs. Sorafenib in Patients with Hepatocellular Carcinoma Refractory to TACE: A Randomized Phase II Trial
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy or safety of continuous TACE and adoption of sorafenib in the patients with TACE failure hepatocellular carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall Survival
Key secondary outcomes Progression-free survival
Objective Response Rate
Change rate of tumor markers
Safety profile

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Continuous TACE
Interventions/Control_2 Sorafenib
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. Patients with advanced hepatocellular carcinoma diagnosed by histology or imaging
2. Patients with hepatocellular carcinoma refractory to TACE according to the following criteria: Lipiodol deposit is less than 50% or multiple new lesions appear 3 months after TACE.
3. Patients who is indicated for sorafenib.
Key exclusion criteria 1.Patients who received sorafenib or molecular target drug in the past 3 months.
2.Patients receiving the treatment (other than study drug or procedure) for HCC.
3.Patients who have an allergic history to the study drug.
4.Patients during pregnancy, breast-feeding, or at risk of becoming pregnant.
5.Patients without indication for TACE.
6.Patients on dialysis.
7.Patients with poorly-controlled hypertension (systolic blood pressure > 170mmHg on medication)
8.Patients with esophageal varices who have a risk for bleeding, or the patients with the history of gastrointestinal hemorrhage within a month.
9.Patients with current or past history of hepatic encephalopathy.
10.Patients with a history of liver transplantation.
11.Patients receiving drugs that affect CYP3A4 or UGT1A9 (e.g.Rifampicin).
12.Patients with other primary malignancies.
13.Patients infected with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS).
14.Patients considered inappropriate by the study investigator.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryosuke Tateishi
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1,Hongo,Bunkyo-ku
TEL 03-3815-5411
Email tateishi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Sato
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1,Hongo,Bunkyo-ku
TEL 03-3815-5411
Homepage URL
Email masayasato0407@gmail.com

Sponsor
Institute The University of Tokyo, Department
of Gastroenterology
Institute
Department

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

Other related organizations
Co-sponsor none
Name of secondary funder(s) Self funding

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
2013 Year 01 Month 31 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
2011 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 31 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011627

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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