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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005818
Receipt No. R000006874
Scientific Title An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Date of disclosure of the study information 2011/06/21
Last modified on 2018/11/07

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Basic information
Public title An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Acronym An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Scientific Title An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Scientific Title:Acronym An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Region
Japan

Condition
Condition advanced hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the safety and efficacy of continued treatment with sorafenib in patients with unresectable advanced HCC after documentation of PD according to the modified RECIST criteria.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety after documentation of the first PD
Key secondary outcomes

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 Sorafenib 400mg twice daily
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)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma
2)Not eligible for local treatment (e.g., surgery, RFA, TAE, and ethanol injection)
3)Lesions measurable with contrast-enhanced computed tomography (CT) or contrast- enhanced magnetic resonance imaging (MRI)
4)No carryover of effects or adverse effects of prior treatment (A washout period of at least 2 weeks will be established before the start of the clinical study for patients who have undergone hepatic resection, percutaneous local treatment, TAE, hepatic arterial infusion, and radiation therapy.)
5)Child-Pugh class A
6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7)Adequate functional reserve of major organs
8)Over 20 years old
9)Capable of complying with requirements with respect to visit days, medication, and laboratory tests
10)The patient provides written informed consent before the start of the clinical study
Key exclusion criteria 1)History of use of sorafenib or another molecular-targeted drug
2)History of systemic chemotherapy
3)Clinically significant ascites (i.e., refractory ascites requiring drainage)
4)History of liver transplantation
5)Esophageal varices with the potential to bleed
6)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder
7)Concurrent or prior hepatic encephalopathy
8)Brain tumor
9)Currently on dialysis
10)Gastrointestinal hemorrhage during the previous month
11)Active double cancer
12)Currently treated with a CYP3A4 inducer (e.g., rifampicin)
13)Serious coexisting disease (NCI CTCAE grade 2 or higher arrhythmia and poorly controlled hypertension)
14)History of hypersensitivity to any component of the study drug
15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to)
16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease
17)Pregnant or nursing
18)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Hamamoto
Organization Keio university school of medicine
Division name division of gastroenterology department of internal medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email yhamamoto@z2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Akutsu
Organization Sapporo Medical University Hospital
Division name First Department of Internal Medicine
Zip code
Address Minami 1, Nishi 16-291, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email akutsu@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 06 Month 21 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 13 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 21 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006874

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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