UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005818 |
|---|---|
| Receipt number | 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 09:20:40 |
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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
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
akutsu@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006874
