UMIN-CTR Clinical Trial

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

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hanshin Association of Molecular Targeted Therapy for HCC

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Osaka City University Hospital
Osaka Medical College Hospital

Name of secondary funder(s)

none

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

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）

Date of disclosure of the study information

2013

Year

12

Month

09

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

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 related 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