UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012484
Receipt number R000014616
Scientific Title Sorafenib vs. half dose Sorafenib and UFT combined therapy in patients with Hepatocellular carcinoma refractory to TACE: Randamized Prospective Study
Date of disclosure of the study information 2013/12/09
Last modified on 2016/01/11 16:05:55

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Basic information

Public title

Sorafenib vs. half dose Sorafenib and UFT combined therapy in patients with Hepatocellular carcinoma refractory to TACE: Randamized Prospective Study

Acronym

Sorafenib vs. half dose Sorafenib and UFT combined therapy in patients with Hepatocellular carcinoma refractory to TACE: Randamized Prospective Study

Scientific Title

Sorafenib vs. half dose Sorafenib and UFT combined therapy in patients with Hepatocellular carcinoma refractory to TACE: Randamized Prospective Study

Scientific Title:Acronym

Sorafenib vs. half dose Sorafenib and UFT combined therapy in patients with Hepatocellular carcinoma refractory to TACE: Randamized Prospective Study

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Compareing the safety and effectiveness in patients with HCC treated by half dose combined therapy of Sorafenib and UFT

Basic objectives2

Others

Basic objectives -Others

Cost-effectiveness

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

overall survival, response rate, rate of overall recurrence, rate of local recurrence, post treatment response rate of Sorafenib, drop out rate of the treatment, relative dose intensity, safety, tumor markers


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Half dose Sorafenib and UFT

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or clinically diagnosed hepatocellular carcinoma (HCC).
2)No indication for surgical resection, local ablation or transarterial chemoembolization refractory or inability
3)Child-Pugh A.
4)Age of 20 years or more.
5)ECOG Performance Status of 0 or 1.
6)Surgical treatment and ablation for hepatocellular carcinoma more than 4 weeks before registration.
7)Maintained function of Cardia, kidney and bone marrow,and satisfying the following: In tests performed 14 or fewer days before enrollment
a.White Blood Cell count >=3,000/mm3
b.Platelet count >=5,0000/uL
c.hemogrobin level >= 8.0 g/dL
d.Total bilirubin < 2.0 mg/dL
e.Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 5 times the upper limit of the study center standard range
f.Prothrombin time activity >= 50%
g.Serum creatinine (Cr) <=1.5 times the upper limit of the study center standard range
h.No abnormality in ECG requiering for treatment
8)At least 3 month survival expected.
9)Written informed consent obtained from the patient.

Key exclusion criteria

1) Vascular invasion
2) Obstruction in the hepatic artery
3) Sever complication such as belows
a.cardiac failure
b.renal failure
c.active infection (except for viral hepatitis)
d.active bleeing in gastrointestinal tract
e.active other cancer
f.Hepatic encepharopathy or severe Mental disorder
4)High fever more than 38 degrees C
5)Not only pregnant or lacting women, but women with suspected pregnancy
6)Inappropriate patients for this study judged by physicians

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Syuhei Nishiguchi

Organization

Hyogo Medical University Hospital

Division name

Hepato-biliary-pancreatic medicine

Zip code


Address

1-1 Mukogawa, Nishinoiya Hyogo 663-8501 JAPAN

TEL

0798-45-6111

Email

hironori@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Nishikawa

Organization

Hyogo College of Medicine

Division name

Division of Hepatobiliary and Pancreatic Disease

Zip code


Address

1-1 Mukogawa, Nishinoiya Hyogo 663-8501 JAPAN

TEL

0798-45-6111

Homepage URL


Email

nishikawa_6392@yahoo.co.jp


Sponsor or person

Institute

Hanshin Association of Molecular Targeted Therapy for HCC

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Osaka City University Hospital
Osaka Medical College Hospital

Name of secondary funder(s)

none


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

兵庫医科大学病院(兵庫県)、大阪市立大学病院(大阪府)、大阪医科大学病院(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 09 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

Enrolling by invitation

Date of protocol fixation

2013 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 09 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 12 Month 04 Day

Last modified on

2016 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name