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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007199
Receipt No. 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

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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
Last 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
1st 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
Institute Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University
Institute
Department

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
URL(English) https://upload.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


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