UMIN-CTR Clinical Trial

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

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall Survival

Key secondary outcomes

Progression-free survival
Objective Response Rate
Change rate of tumor markers
Safety profile

Study type

Interventional

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

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

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

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

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

Institute

The University of Tokyo, Department
of Gastroenterology

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

none

Name of secondary funder(s)

Self funding

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

01

Month

31

Day

Last modified on

2017

Year

08

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011627