UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007199
Receipt number R000008479
Scientific Title Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.
Date of disclosure of the study information 2012/02/01
Last modified on 2014/05/30 09:45:55

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Basic information

Public title

Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.

Acronym

Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.

Scientific Title

Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.

Scientific Title:Acronym

Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and effectiveness of S-1+Sorafenib in patients with advanced hepatocellular carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Time to progression

Key secondary outcomes

Overall survival
Response rate
Disease control rate
Incidence of adversed effect


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

S-1 80%dose 2weeks on, 1week off
Sorafenib 800mg/day everyday

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who have been diagnosed with hepatocellular carcinoma by histologically or typical diagnostic images
2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy)
3)Systemic chemotherapy naive
4)At least 1 target lesion measurable
5)Performance status (ECOG scale): 0,1
6)Age >= 20 years
7)Adequate bone marrow, liver, renal and cardiac function as assessed by the following
(a)Neutrophil >= 1500/mm3
(b)Hemoglobin >= 9.0 g/dl
(c)Platelets >= 50000/mm3
(d)Total bilirubin < 3.0mg/dl
(e)Liver transaminases <= 10 x Upper limit of Normal(ULN)
(f)ALB >= 2.8 g/dl
(g)Cre <= ULN
(h)PT >= 40%
8)Child-pugh A
9)Patients can take food and drugs oral
10)Life expectancy of at least 12 weeks
11)Written informed consent

Key exclusion criteria

1)Previous therapy for hepatocellular carcinoma within 30days before study entry
2)Major surgery within 30 days before study entry or surgery within 15 days before study entry
3)Portal vein tumor thrombus in the main trunk
4)Uncontrollable hypertension
5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics
6)get an albumin preparation or a blood transfusion within 30 days before study entry
7)Hepatoencepharopathy. Brain lesions with clinical symptoms
8)Central nerve system tumor(including brain metastasis)
9)Bone metastasis with clinical symptoms
10)Active infection(except HBV and HCV infection)
11)Evidence of serious gastrointestinal bleeding within 30days before study entry
12)Gastro-esophageal varices requiring preventive treatment
13)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment
14)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence)
15)Severe hypersensitivity of TS-1 or sorafenib
16)Severe complication
17)Any patients judged by the investigator to be unfit to participate in the study

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Yokosuka

Organization

Chiba University

Division name

Department of medicine and clinical oncology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiko Ooka

Organization

Chiba University

Division name

Department of medicine and clinical oncology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

043-226-2083

Homepage URL


Email



Sponsor or person

Institute

Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

Health Labour Sciences Research Grant

Organization

Division

Category of Funding Organization

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

2012 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2013 Year 09 Month 01 Day

Date of closure to data entry

2013 Year 09 Month 15 Day

Date trial data considered complete

2013 Year 10 Month 01 Day

Date analysis concluded

2013 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 01 Day

Last modified on

2014 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008479


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name